Register entryShortage reported
- Registered sites
- 1
- Active NDC listings
- 513
- Labeller names
- 2
- Live patents
- 34
- Shortage listings
- 20
- Countries
- 1
- Base
- Ireland
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1Repackaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Amneal Ireland Limited | Cahir Road, Cashel, E25 XD51 , Ireland (IRL) | Analytical testing, Labelling, Finished drug manufacture, Packaging, Repackaging | 3012344329985619862 |
Alert
Drug shortage listings
20| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Dexmedetomidine Hydrochloride InjectionAnesthesia | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1389-7) | Current | Available | 10 Apr 202017 Jun 2026 |
| Dexmedetomidine Hydrochloride InjectionAnesthesia | Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 50 mL (NDC 70121-1388-1) | Current | Available | 10 Apr 202017 Jun 2026 |
| Dexmedetomidine Hydrochloride InjectionAnesthesia | Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 100 mL (NDC 70121-1389-1) | Current | Available | 10 Apr 202017 Jun 2026 |
| Dexmedetomidine Hydrochloride InjectionAnesthesia | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1388-8) | Current | Available | 10 Apr 202017 Jun 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 65162-027-09) | Current | Available | 14 Jul 202317 Jun 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 65162-024-09) | Current | Available | 14 Jul 202317 Jun 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 65162-028-09) | Current | Available | 14 Jul 202317 Jun 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 65162-023-09) | Current | Available | 14 Jul 202317 Jun 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 65162-025-09) | Current | Available | 14 Jul 202317 Jun 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 65162-026-09) | Current | Available | 14 Jul 202317 Jun 2026 |
| Methylprednisolone Acetate InjectionRheumatology | Methylprednisolone Acetate, Injection, 40 mg/1 mL (NDC 70121-1573-5) | Current | Available | 15 Dec 202117 Jun 2026 |
| Methylprednisolone Acetate InjectionRheumatology | Methylprednisolone Acetate, Injection, 80 mg/1 mL (NDC 70121-1574-1) | Current | Available | 15 Dec 202117 Jun 2026 |
| Methylprednisolone Acetate InjectionRheumatology | Methylprednisolone Acetate, Injection, 80 mg/1 mL (NDC 70121-1574-5) | Current | Available | 15 Dec 202117 Jun 2026 |
| Methylprednisolone Acetate InjectionRheumatology | Methylprednisolone Acetate, Injection, 40 mg/1 mL (NDC 70121-1573-1) | Current | Limited Availability | 15 Dec 202117 Jun 2026 |
| Donepezil Hydrochloride; Memantine Hydrochloride Capsule, Extended ReleaseNeurology | Donepezil Hydrochloride; Memantine Hydrochloride, Capsule, Extended Release, 10 mg; 28 mg (NDC 69238-1247-3) | To Be Discontinued | - | 15 Jun 202615 Jun 2026 |
| Donepezil Hydrochloride; Memantine Hydrochloride Capsule, Extended ReleaseNeurology | Donepezil Hydrochloride; Memantine Hydrochloride, Capsule, Extended Release, 10 mg; 14 mg (NDC 69238-1248-3) | To Be Discontinued | - | 15 Jun 202615 Jun 2026 |
| Nitrofurantoin Oral SuspensionAnti-Infective, Other | Nitrofurantoin, Oral Suspension, 25 mg/5 mL (NDC 69238-2512-9) | To Be Discontinued | - | 10 Apr 202610 Apr 2026 |
| Dapsone GelDermatology | Dapsone, Gel, 7.5% (NDC 69238-1627-6) | To Be Discontinued | - | 27 Mar 202627 Mar 2026 |
| Clindamycin Palmitate Hydrochloride InjectionAnti-Infective | Clindamycin Palmitate Hydrochloride, Injection, 75 mg/5 mL (NDC 53746-468-19) | To Be Discontinued | - | 26 Mar 202626 Mar 2026 |
| Sodium Oxybate SolutionPsychiatry | Sodium Oxybate, Solution, .5 g/1 mL (NDC 69238-2391-1) | To Be Discontinued | - | 29 Dec 202529 Dec 2025 |
Catalogue
Drug listings by form and route
513513 active NDC listings: 499 human prescription drug, 14 human otc drug. By marketing category: ANDA 447, NDA 51, BLA 9, UNAPPROVED DRUG OTHER 6.
| Dosage form | NDCs |
|---|---|
| tablet | 117 |
| injection | 53 |
| injection, solution | 53 |
| capsule | 46 |
| tablet, film coated | 43 |
| tablet, extended release | 28 |
| solution | 17 |
| capsule, extended release | 16 |
| injection, suspension | 16 |
| tablet, film coated, extended release | 14 |
| kit | 12 |
| injection, powder, lyophilized, for solution | 10 |
| patch, extended release | 10 |
| capsule, liquid filled | 8 |
| injection, powder, for solution | 7 |
| Route | NDCs |
|---|---|
| oral | 324 |
| intravenous | 120 |
| intramuscular | 45 |
| intra-articular | 23 |
| subcutaneous | 21 |
| transdermal | 14 |
| intrathecal | 12 |
| topical | 9 |
| intralesional | 8 |
| soft tissue | 8 |
| intravascular | 6 |
| rectal | 6 |
| epidural | 4 |
| infiltration | 4 |
| intracavitary | 4 |
| Labeller name on the listing | NDCs |
|---|---|
| amneal pharmaceuticals llc | 486 |
| amneal pharmaceuticals private limited | 27 |
Exclusivity
Patents and exclusivities
34| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8907099 | ONGENTYSopicapone | substance | May 2027 |
| 8168793 | ONGENTYSopicapone | substance, product | Oct 2027 |
| 9745290 | ONGENTYSopicapone | product | Oct 2027 |
| 8524746 | ONGENTYSopicapone | use | Jul 2029 |
| 10071085 | ONGENTYSopicapone | product | Mar 2030 |
| 10583130 | ONGENTYSopicapone | use | Mar 2030 |
| 12129247 | ONGENTYSopicapone | use | Jan 2032 |
| 9630955 | ONGENTYSopicapone | substance, product | Dec 2032 |
| 9855335 | TIGECYCLINEtigecycline | product | Apr 2033 |
| 10881617 | PYRIDOSTIGMINE BROMIDEpyridostigmine bromide | product | Jun 2038 |
| 10925833 | PYRIDOSTIGMINE BROMIDEpyridostigmine bromide | product | Jun 2038 |
| 10987311 | PYRIDOSTIGMINE BROMIDEpyridostigmine bromide | product | Jun 2038 |
| 11229606 | PYRIDOSTIGMINE BROMIDEpyridostigmine bromide | product | Jun 2038 |
| 11478425 | PYRIDOSTIGMINE BROMIDEpyridostigmine bromide | product | Jun 2038 |
| 11666536 | PYRIDOSTIGMINE BROMIDEpyridostigmine bromide | product | Jun 2038 |
| 11911515 | PYRIDOSTIGMINE BROMIDEpyridostigmine bromide | product | Jun 2038 |
| 12042559 | PYRIDOSTIGMINE BROMIDEpyridostigmine bromide | product | Jun 2038 |
| 12233166 | PYRIDOSTIGMINE BROMIDEpyridostigmine bromide | product | Jun 2038 |
| 10532049 | BREKIYA (AUTOINJECTOR)dihydroergotamine mesylate | product | Feb 2039 |
| 11304942 | BREKIYA (AUTOINJECTOR)dihydroergotamine mesylate | product | Feb 2039 |
| 11819501 | BREKIYA (AUTOINJECTOR)dihydroergotamine mesylate | use | Feb 2039 |
| 12533351 | BREKIYA (AUTOINJECTOR)dihydroergotamine mesylate | product | Feb 2039 |
| 11541043 | BREKIYA (AUTOINJECTOR)dihydroergotamine mesylate | product | Mar 2039 |
| 12329749 | BREKIYA (AUTOINJECTOR)dihydroergotamine mesylate | product | May 2039 |
| 11083712 | BREKIYA (AUTOINJECTOR)dihydroergotamine mesylate | product | Jun 2039 |
| 12414941 | BREKIYA (AUTOINJECTOR)dihydroergotamine mesylate | product | Aug 2039 |
Catalogue
Marketed products
513Showing 150 of 513.
| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ABIRATERONE ACETATE | ABIRATERONE | tablet, oral | 60219-1754ANDA |
| ALBENZA | albendazole | tablet, film coated, oral | 64896-693NDA |
| ALYMSYS | bevacizumab-maly | injection, solution, intravenous | 70121-1754BLA |
| ALYMSYS | bevacizumab-maly | injection, solution, intravenous | 70121-1755BLA |
| ATOVAQUONE | ATOVAQUONE | suspension, oral | 65162-693ANDA |
| AZACITIDINE | AZACITIDINE | injection, powder, lyophilized, for solution, intravenous, subcutaneous | 70121-1237ANDA |
| Abiraterone Acetate | Abiraterone | tablet, oral | 60219-1165ANDA |
| Acebutolol Hydrochloride | Acebutolol Hydrochloride | capsule, oral | 65162-669ANDA |
| Acebutolol Hydrochloride | Acebutolol Hydrochloride | capsule, oral | 65162-670ANDA |
| Acetaminophen and Codeine | Acetaminophen and Codeine | tablet, oral | 65162-033ANDA |
| Activella | Estradiol/norethindrone acetate | tablet, film coated, oral | 60846-231NDA |
| Activella | Estradiol/norethindrone acetate | tablet, film coated, oral | 60846-232NDA |
| Acyclovir | Acyclovir | ointment, topical | 65162-835ANDA |
| Acyclovir | Acyclovir | cream, topical | 65162-836ANDA |
| Alosetron Hydrochloride | Alosetron Hydrochloride | tablet, film coated, oral | 65162-248ANDA |
| Alosetron Hydrochloride | Alosetron Hydrochloride | tablet, film coated, oral | 65162-249ANDA |
| Alprazolam | Alprazolam | tablet, extended release, oral | 65162-809ANDA |
| Alprazolam | Alprazolam | tablet, extended release, oral | 65162-810ANDA |
| Alprazolam | Alprazolam | tablet, extended release, oral | 65162-812ANDA |
| Alprazolam | Alprazolam | tablet, extended release, oral | 65162-813ANDA |
| Aminocaproic acid | Aminocaproic acid | tablet, oral | 69238-1637ANDA |
| Argatroban | Argatroban | injection, solution, intravenous | 70121-1037ANDA |
| Aripiprazole | Aripiprazole | solution, oral | 65162-893ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 65162-896ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 65162-897ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 65162-898ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 65162-899ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 65162-901ANDA |
| Aripiprazole | Aripiprazole | tablet, oral | 65162-902ANDA |
| Arsenic Trioxide | Arsenic Trioxide | injection, solution, intravenous | 70121-1483ANDA |
| Arsenic Trioxide | Arsenic Trioxide | injection, solution, intravenous | 70121-1658ANDA |
| Aspirin and Extended-Release Dipyridamole | Aspirin and Extended-Release Dipyridamole | capsule, oral | 65162-596ANDA |
| Azelastine Hydrochloride | Azelastine | spray, metered, nasal | 65162-676ANDA |
| BORUZU | Bortezomib | injection, intravenous, subcutaneous | 70121-2484NDA |
| BREKIYA | Dihydroergotamine Mesylate | injection, subcutaneous | 64896-509NDA |
| Benazepril Hydrochloride | Benazepril Hydrochloride | tablet, oral | 65162-751ANDA |
| Benazepril Hydrochloride | Benazepril Hydrochloride | tablet, oral | 65162-752ANDA |
| Benazepril Hydrochloride | Benazepril Hydrochloride | tablet, oral | 65162-753ANDA |
| Benazepril Hydrochloride | Benazepril Hydrochloride | tablet, oral | 65162-754ANDA |
| Benzonatate | Benzonatate | capsule, liquid filled, oral | 65162-536ANDA |
| Benzonatate | Benzonatate | capsule, liquid filled, oral | 65162-537ANDA |
| Bethanechol Chloride | Bethanechol Chloride | tablet, oral | 65162-571ANDA |
| Bethanechol Chloride | Bethanechol Chloride | tablet, oral | 65162-572ANDA |
| Bethanechol Chloride | Bethanechol Chloride | tablet, oral | 65162-573ANDA |
| Bethanechol Chloride | Bethanechol Chloride | tablet, oral | 65162-574ANDA |
| Boncresa | denosumab-mobz | injection, solution, subcutaneous | 70121-2702BLA |
| Budesonide | Budesonide | capsule, delayed release, oral | 65162-778ANDA |
| Buprenorphine HCl and Naloxone HCl | Buprenorphine and Naloxone | tablet, sublingual | 65162-415ANDA |
| Buprenorphine HCl and Naloxone HCl | Buprenorphine and Naloxone | tablet, sublingual | 65162-416ANDA |
| Busulfan | Busulfan | injection, intravenous | 70121-1244ANDA |
| CALCIUM GLUCONATE | calcium gluconate | injection, solution, intravenous | 80830-2362ANDA |
| CALCIUM GLUCONATE | calcium gluconate | injection, solution, intravenous | 80830-2363ANDA |
| CREXONT | carbidopa and levodopa | capsule, extended release, oral | 64896-967NDA |
| CREXONT | carbidopa and levodopa | capsule, extended release, oral | 64896-968NDA |
| CREXONT | carbidopa and levodopa | capsule, extended release, oral | 64896-969NDA |
| CREXONT | carbidopa and levodopa | capsule, extended release, oral | 64896-970NDA |
| CUPRIC CHLORIDE | CUPRIC CHLORIDE | injection, solution, intravenous | 80830-2301ANDA |
| Calcitriol | Calcitriol | capsule, oral | 65162-519ANDA |
| Calcitriol | Calcitriol | capsule, oral | 65162-576ANDA |
| Cetirizine Hydrochloride | Cetirizine | solution, oral | 65162-003ANDA |
| Cetirizine Hydrochloride | Cetirizine | solution, oral | 65162-005ANDA |
| Cetirizine Hydrochloride | Cetirizine | tablet, oral | 65162-045ANDA |
| Cetirizine Hydrochloride | Cetirizine | tablet, oral | 65162-046ANDA |
| Cetirizine Hydrochloride | Cetirizine | solution, oral | 65162-684ANDA |
| Cetirizine Hydrochloride Hives Relief | Cetirizine | tablet, oral | 65162-145ANDA |
| Chlorthalidone | Chlorthalidone | tablet, oral | 65162-247ANDA |
| Chlorthalidone | Chlorthalidone | tablet, oral | 65162-250ANDA |
| Cinacalcet Hydrochloride | Cinacalcet | tablet, oral | 65162-155ANDA |
| Cinacalcet Hydrochloride | Cinacalcet | tablet, oral | 65162-157ANDA |
| Cinacalcet Hydrochloride | Cinacalcet | tablet, oral | 65162-213ANDA |
| Citalopram | Citalopram | tablet, oral | 65162-052ANDA |
| Citalopram | Citalopram | tablet, oral | 65162-053ANDA |
| Citalopram | Citalopram | tablet, oral | 65162-054ANDA |
| Clindamycin Palmitate Hydrochloride (Pediatric) | Clindamycin Palmitate Hydrochloride | powder, for solution, oral | 65162-468ANDA |
| Clobetasol Propionate | Clobetasol Propionate | cream, topical | 69238-1532ANDA |
| Clofarabine | Clofarabine | injection, intravenous | 70121-1236ANDA |
| Clopidogrel | Clopidogrel | tablet, oral | 65162-414ANDA |
| Colchicine | Colchicine | tablet, oral | 65162-710ANDA |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | tablet, film coated, oral | 65162-540ANDA |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | tablet, film coated, oral | 65162-541ANDA |
| Cyclophosphamide | Cyclophosphamide | injection, powder, for solution, intravenous, oral | 70121-1238ANDA |
| Cyclophosphamide | Cyclophosphamide | injection, powder, for solution, intravenous, oral | 70121-1239ANDA |
| Cyclophosphamide | Cyclophosphamide | injection, powder, for solution, intravenous, oral | 70121-1240ANDA |
| DEXEDRINE SPANSULE | dextroamphetamine sulfate | capsule, extended release, oral | 64896-673NDA |
| DEXEDRINE SPANSULE | dextroamphetamine sulfate | capsule, extended release, oral | 64896-674NDA |
| DEXEDRINE SPANSULE | dextroamphetamine sulfate | capsule, extended release, oral | 64896-675NDA |
| DOTTI | Estradiol | patch, extended release, transdermal | 65162-989ANDA |
| DOTTI | Estradiol | patch, extended release, transdermal | 65162-992ANDA |
| DOTTI | Estradiol | patch, extended release, transdermal | 65162-993ANDA |
| DOTTI | Estradiol | patch, extended release, transdermal | 65162-995ANDA |
| DOTTI | Estradiol | patch, extended release, transdermal | 65162-997ANDA |
| Dapsone | Dapsone | gel, topical | 65162-339ANDA |
| Decitabine | decitabine | injection, powder, lyophilized, for solution, intravenous | 70121-1644ANDA |
| Demeclocycline Hydrochloride | Demeclocycline | tablet, oral | 65162-554ANDA |
| Demeclocycline Hydrochloride | Demeclocycline | tablet, oral | 65162-555ANDA |
| Desipramine Hydrochloride | Desipramine | tablet, film coated, oral | 69238-1053ANDA |
| Desipramine Hydrochloride | Desipramine | tablet, film coated, oral | 69238-1055ANDA |
| Desipramine Hydrochloride | Desipramine | tablet, film coated, oral | 69238-1057ANDA |
| Desipramine Hydrochloride | Desipramine | tablet, film coated, oral | 69238-1059ANDA |
| Desipramine Hydrochloride | Desipramine | tablet, film coated, oral | 69238-1061ANDA |
| Desipramine Hydrochloride | Desipramine | tablet, film coated, oral | 69238-1063ANDA |
| Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | injection, solution, intramuscular, intravenous | 70121-1399ANDA |
| Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | injection, solution, intra-articular, intralesional, intramuscular, intravenous, soft tissue | 70121-1450ANDA |
| Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | injection, solution, intra-articular, intralesional, intramuscular, intravenous, soft tissue | 70121-1451ANDA |
| Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | injection, solution, intra-articular, intralesional, intramuscular, intravenous, soft tissue | 70121-1452ANDA |
| Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride | injection, solution, intravenous | 70121-1388ANDA |
| Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride | injection, solution, intravenous | 70121-1389ANDA |
| Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride in Sodium Chloride | injection, intravenous | 70121-1711ANDA |
| Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride in Sodium Chloride | injection, intravenous | 70121-1712ANDA |
| Dextromethorphan Polistirex Extended-Release | Dextromethorphan Polistirex | suspension, oral | 65162-700ANDA |
| Dextromethorphan Polistirex Extended-Release | Dextromethorphan Polistirex | suspension, oral | 65162-799ANDA |
| Diclofenac Sodium | Diclofenac | solution, topical | 65162-683ANDA |
| Diclofenac Sodium | Diclofenac | solution, topical | 65162-911ANDA |
| Diclofenac Sodium and Misoprostol | Diclofenac Sodium and Misoprostol | tablet, delayed release, oral | 65162-436ANDA |
| Diclofenac Sodium and Misoprostol | Diclofenac Sodium and Misoprostol | tablet, delayed release, oral | 65162-438ANDA |
| Difluprednate | Difluprednate ophthalmic | emulsion, ophthalmic | 69238-1380ANDA |
| Divalproex Sodium | Divalproex Sodium | tablet, extended release, oral | 65162-755ANDA |
| Divalproex Sodium | Divalproex Sodium | tablet, extended release, oral | 65162-757ANDA |
| Docetaxel | Docetaxel | injection, intravenous | 70121-1221ANDA |
| Docetaxel | Docetaxel | injection, intravenous | 70121-1222ANDA |
| Docetaxel | Docetaxel | injection, intravenous | 70121-1223ANDA |
| Doxepin Hydrochloride | Doxepin Hydrochloride | capsule, oral | 69238-1166ANDA |
| Doxepin Hydrochloride | Doxepin Hydrochloride | capsule, oral | 69238-1170ANDA |
| Doxepin Hydrochloride | Doxepin Hydrochloride | capsule, oral | 69238-1171ANDA |
| Doxepin Hydrochloride | Doxepin Hydrochloride | capsule, oral | 69238-1172ANDA |
| Doxepin Hydrochloride | Doxepin Hydrochloride | capsule, oral | 69238-1173ANDA |
| Doxorubicin Hydrochloride | Doxorubicin | injection, powder, lyophilized, for solution, intravenous | 70121-1218ANDA |
| Doxorubicin Hydrochloride | Doxorubicin Hydrochloride | injection, powder, lyophilized, for solution, intravenous | 70121-1219ANDA |
| Doxycycline | Doxycycline | injection, powder, lyophilized, for solution, intravenous | 70121-1616ANDA |
| Dutasteride | Dutasteride | capsule, oral | 65162-750ANDA |
| EPINEPHRINE | epinephrine | injection, intramuscular, intravenous, subcutaneous | 80830-1659ANDA |
| EluRyng | Etonogestrel and Ethinyl Estradiol | ring, vaginal | 65162-469ANDA |
| Entecavir | Entecavir | tablet, film coated, oral | 65162-446ANDA |
| Entecavir | Entecavir | tablet, film coated, oral | 65162-449ANDA |
| Ephedrine Sulfate | Ephedrine Sulfate | injection, intravenous | 70121-1637ANDA |
| Escitalopram Oxalate | Escitalopram Oxalate | tablet, film coated, oral | 65162-019ANDA |
| Escitalopram Oxalate | Escitalopram Oxalate | tablet, film coated, oral | 65162-020ANDA |
| Escitalopram Oxalate | Escitalopram Oxalate | tablet, film coated, oral | 65162-021ANDA |
| Escitalopram Oxalate | Escitalopram | solution, oral | 65162-705ANDA |
| Esmolol Hydrochloride | Esmolol Hydrochloride in Sodium Chloride | injection, intravenous | 70121-1716ANDA |
| Esmolol Hydrochloride | Esmolol Hydrochloride in Sodium Chloride | injection, intravenous | 70121-1717ANDA |
| Exenatide | Exenatide | injection, subcutaneous | 70121-1685ANDA |
| Exenatide | Exenatide | injection, subcutaneous | 70121-1686ANDA |
| Extended Phenytoin Sodium | Phenytoin Sodium | capsule, oral | 65162-212ANDA |
| FENOFIBRATE | FENOFIBRATE | tablet, oral | 60219-5511ANDA |
| FENOFIBRATE | FENOFIBRATE | tablet, oral | 60219-5522ANDA |
| FOCINVEZ | FOSAPREPITANT DIMEGLUMINE | injection, intravenous | 70121-2631NDA |
| FYLNETRA | pegfilgrastim | injection, subcutaneous | 70121-1627BLA |
| Felbamate | Felbamate | suspension, oral | 65162-686ANDA |
| Felbamate | Felbamate | tablet, oral | 65162-734ANDA |
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Enquiry
Common questions
- Is Amneal Ireland Limited FDA approved?
- Amneal Ireland Limited holds 1 FDA-registered establishment in Ireland. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Amneal Ireland Limited's drugs manufactured?
- The FDA register lists Cashel. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, repackaging.
- What drugs does Amneal Ireland Limited make?
- 513 products are listed under Amneal Ireland Limited in the openFDA NDC Directory, most often as tablet; injection; injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any Amneal Ireland Limited products in shortage?
- 14 presentations are currently listed in the FDA drug shortage database under Amneal Ireland Limited, covering Dexmedetomidine Hydrochloride Injection, Lisdexamfetamine Dimesylate Capsule, Methylprednisolone Acetate Injection.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.