Register entryShortage reported
Amneal Ireland Limited
- Registered sites
- 1
- Drug products
- 483
- Live patents
- 34
- Countries
- 1
- Base
- Ireland
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingLabellingFinished drug manufacturePackagingRepackaging
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Amneal Ireland Limited | CashelIreland | Analytical testing, Labelling, Finished drug manufacture, Packaging, Repackaging | 3012344329 |
Alert
Products in shortage
14| Drug | Presentation | Availability |
|---|---|---|
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1389-7) | Available |
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 70121-1388-8) | Available |
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 50 mL (NDC 70121-1388-1) | Available |
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 4 mcg/mL, 100 mL (NDC 70121-1389-1) | Available |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 65162-025-09) | Available |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 65162-024-09) | Available |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 65162-026-09) | Available |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 65162-028-09) | Available |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 65162-027-09) | Available |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 65162-023-09) | Available |
| Methylprednisolone Acetate Injection | Methylprednisolone Acetate, Injection, 80 mg/1 mL (NDC 70121-1574-5) | Available |
| Methylprednisolone Acetate Injection | Methylprednisolone Acetate, Injection, 40 mg/1 mL (NDC 70121-1573-1) | Limited Availability |
| Methylprednisolone Acetate Injection | Methylprednisolone Acetate, Injection, 80 mg/1 mL (NDC 70121-1574-1) | Available |
| Methylprednisolone Acetate Injection | Methylprednisolone Acetate, Injection, 40 mg/1 mL (NDC 70121-1573-5) | Available |
Exclusivity
Patents
34Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| BREKIYA (AUTOINJECTOR) | DIHYDROERGOTAMINE MESYLATE | Feb 2039 |
| BREKIYA (AUTOINJECTOR) | DIHYDROERGOTAMINE MESYLATE | Mar 2039 |
| BREKIYA (AUTOINJECTOR) | DIHYDROERGOTAMINE MESYLATE | May 2039 |
| BREKIYA (AUTOINJECTOR) | DIHYDROERGOTAMINE MESYLATE | Jun 2039 |
| BREKIYA (AUTOINJECTOR) | DIHYDROERGOTAMINE MESYLATE | Aug 2039 |
| ONGENTYS | OPICAPONE | May 2027 |
| ONGENTYS | OPICAPONE | Oct 2027 |
| ONGENTYS | OPICAPONE | Jul 2029 |
| ONGENTYS | OPICAPONE | Mar 2030 |
| ONGENTYS | OPICAPONE | Jan 2032 |
| ONGENTYS | OPICAPONE | Dec 2032 |
| PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | Jun 2038 |
| TIGECYCLINE | TIGECYCLINE | Apr 2033 |
Catalogue
Marketed products
483Showing 150 of 483.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| ALBENZA | albendazole | TABLET, FILM COATED | NDA |
| ALYMSYS | bevacizumab-maly | INJECTION, SOLUTION | BLA |
| ALYMSYS | bevacizumab-maly | INJECTION, SOLUTION | BLA |
| ATOVAQUONE | ATOVAQUONE | SUSPENSION | ANDA |
| AZACITIDINE | AZACITIDINE | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| Acebutolol Hydrochloride | Acebutolol Hydrochloride | CAPSULE | ANDA |
| Acebutolol Hydrochloride | Acebutolol Hydrochloride | CAPSULE | ANDA |
| Acetaminophen and Codeine | Acetaminophen and Codeine | TABLET | ANDA |
| Activella | Estradiol/norethindrone acetate | TABLET, FILM COATED | NDA |
| Activella | Estradiol/norethindrone acetate | TABLET, FILM COATED | NDA |
| Acyclovir | Acyclovir | OINTMENT | ANDA |
| Acyclovir | Acyclovir | CREAM | ANDA |
| Alosetron Hydrochloride | Alosetron Hydrochloride | TABLET, FILM COATED | ANDA |
| Alosetron Hydrochloride | Alosetron Hydrochloride | TABLET, FILM COATED | ANDA |
| Alprazolam | Alprazolam | TABLET, EXTENDED RELEASE | ANDA |
| Alprazolam | Alprazolam | TABLET, EXTENDED RELEASE | ANDA |
| Alprazolam | Alprazolam | TABLET, EXTENDED RELEASE | ANDA |
| Alprazolam | Alprazolam | TABLET, EXTENDED RELEASE | ANDA |
| Aminocaproic acid | Aminocaproic acid | TABLET | ANDA |
| Argatroban | Argatroban | INJECTION, SOLUTION | ANDA |
| Aripiprazole | Aripiprazole | SOLUTION | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Aripiprazole | Aripiprazole | TABLET | ANDA |
| Arsenic Trioxide | Arsenic Trioxide | INJECTION, SOLUTION | ANDA |
| Arsenic Trioxide | Arsenic Trioxide | INJECTION, SOLUTION | ANDA |
| Aspirin and Extended-Release Dipyridamole | Aspirin and Extended-Release Dipyridamole | CAPSULE | ANDA |
| Azelastine Hydrochloride | Azelastine | SPRAY, METERED | ANDA |
| BORUZU | Bortezomib | INJECTION | NDA |
| BREKIYA | Dihydroergotamine Mesylate | INJECTION | NDA |
| Benazepril Hydrochloride | Benazepril Hydrochloride | TABLET | ANDA |
| Benazepril Hydrochloride | Benazepril Hydrochloride | TABLET | ANDA |
| Benazepril Hydrochloride | Benazepril Hydrochloride | TABLET | ANDA |
| Benazepril Hydrochloride | Benazepril Hydrochloride | TABLET | ANDA |
| Benzonatate | Benzonatate | CAPSULE, LIQUID FILLED | ANDA |
| Benzonatate | Benzonatate | CAPSULE, LIQUID FILLED | ANDA |
| Bethanechol Chloride | Bethanechol Chloride | TABLET | ANDA |
| Bethanechol Chloride | Bethanechol Chloride | TABLET | ANDA |
| Bethanechol Chloride | Bethanechol Chloride | TABLET | ANDA |
| Bethanechol Chloride | Bethanechol Chloride | TABLET | ANDA |
| Boncresa | denosumab-mobz | INJECTION, SOLUTION | BLA |
| Budesonide | Budesonide | CAPSULE, DELAYED RELEASE | ANDA |
| Buprenorphine HCl and Naloxone HCl | Buprenorphine and Naloxone | TABLET | ANDA |
| Buprenorphine HCl and Naloxone HCl | Buprenorphine and Naloxone | TABLET | ANDA |
| Busulfan | Busulfan | INJECTION | ANDA |
| CALCIUM GLUCONATE | calcium gluconate | INJECTION, SOLUTION | ANDA |
| CALCIUM GLUCONATE | calcium gluconate | INJECTION, SOLUTION | ANDA |
| CREXONT | carbidopa and levodopa | CAPSULE, EXTENDED RELEASE | NDA |
| CREXONT | carbidopa and levodopa | CAPSULE, EXTENDED RELEASE | NDA |
| CREXONT | carbidopa and levodopa | CAPSULE, EXTENDED RELEASE | NDA |
| CREXONT | carbidopa and levodopa | CAPSULE, EXTENDED RELEASE | NDA |
| CUPRIC CHLORIDE | CUPRIC CHLORIDE | INJECTION, SOLUTION | ANDA |
| Calcitriol | Calcitriol | CAPSULE | ANDA |
| Calcitriol | Calcitriol | CAPSULE | ANDA |
| Cetirizine Hydrochloride | Cetirizine | SOLUTION | ANDA |
| Cetirizine Hydrochloride | Cetirizine | SOLUTION | ANDA |
| Cetirizine Hydrochloride | Cetirizine | TABLET | ANDA |
| Cetirizine Hydrochloride | Cetirizine | TABLET | ANDA |
| Cetirizine Hydrochloride | Cetirizine | SOLUTION | ANDA |
| Cetirizine Hydrochloride Hives Relief | Cetirizine | TABLET | ANDA |
| Chlorthalidone | Chlorthalidone | TABLET | ANDA |
| Chlorthalidone | Chlorthalidone | TABLET | ANDA |
| Cinacalcet Hydrochloride | Cinacalcet | TABLET | ANDA |
| Cinacalcet Hydrochloride | Cinacalcet | TABLET | ANDA |
| Cinacalcet Hydrochloride | Cinacalcet | TABLET | ANDA |
| Citalopram | Citalopram | TABLET | ANDA |
| Citalopram | Citalopram | TABLET | ANDA |
| Citalopram | Citalopram | TABLET | ANDA |
| Clindamycin Palmitate Hydrochloride (Pediatric) | Clindamycin Palmitate Hydrochloride | POWDER, FOR SOLUTION | ANDA |
| Clofarabine | Clofarabine | INJECTION | ANDA |
| Clopidogrel | Clopidogrel | TABLET | ANDA |
| Colchicine | Colchicine | TABLET | ANDA |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | TABLET, FILM COATED | ANDA |
| Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | TABLET, FILM COATED | ANDA |
| Cyclophosphamide | Cyclophosphamide | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Cyclophosphamide | Cyclophosphamide | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Cyclophosphamide | Cyclophosphamide | INJECTION, POWDER, FOR SOLUTION | ANDA |
| DEXEDRINE SPANSULE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE | NDA |
| DEXEDRINE SPANSULE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE | NDA |
| DEXEDRINE SPANSULE | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE | NDA |
| DOTTI | Estradiol | PATCH, EXTENDED RELEASE | ANDA |
| DOTTI | Estradiol | PATCH, EXTENDED RELEASE | ANDA |
| DOTTI | Estradiol | PATCH, EXTENDED RELEASE | ANDA |
| DOTTI | Estradiol | PATCH, EXTENDED RELEASE | ANDA |
| DOTTI | Estradiol | PATCH, EXTENDED RELEASE | ANDA |
| Dapsone | Dapsone | GEL | ANDA |
| Decitabine | decitabine | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| Demeclocycline Hydrochloride | Demeclocycline | TABLET | ANDA |
| Demeclocycline Hydrochloride | Demeclocycline | TABLET | ANDA |
| Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | INJECTION, SOLUTION | ANDA |
| Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | INJECTION, SOLUTION | ANDA |
| Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | INJECTION, SOLUTION | ANDA |
| Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | INJECTION, SOLUTION | ANDA |
| Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride | INJECTION, SOLUTION | ANDA |
| Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride | INJECTION, SOLUTION | ANDA |
| Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride in Sodium Chloride | INJECTION | ANDA |
| Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride in Sodium Chloride | INJECTION | ANDA |
| Dextromethorphan Polistirex Extended-Release | Dextromethorphan Polistirex | SUSPENSION | ANDA |
| Dextromethorphan Polistirex Extended-Release | Dextromethorphan Polistirex | SUSPENSION | ANDA |
| Diclofenac Sodium | Diclofenac | SOLUTION | ANDA |
| Diclofenac Sodium | Diclofenac | SOLUTION | ANDA |
| Diclofenac Sodium and Misoprostol | Diclofenac Sodium and Misoprostol | TABLET, DELAYED RELEASE | ANDA |
| Diclofenac Sodium and Misoprostol | Diclofenac Sodium and Misoprostol | TABLET, DELAYED RELEASE | ANDA |
| Divalproex Sodium | Divalproex Sodium | TABLET, EXTENDED RELEASE | ANDA |
| Divalproex Sodium | Divalproex Sodium | TABLET, EXTENDED RELEASE | ANDA |
| Docetaxel | Docetaxel | INJECTION | ANDA |
| Docetaxel | Docetaxel | INJECTION | ANDA |
| Docetaxel | Docetaxel | INJECTION | ANDA |
| Doxorubicin Hydrochloride | Doxorubicin | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| Doxorubicin Hydrochloride | Doxorubicin Hydrochloride | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| Doxycycline | Doxycycline | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| Dutasteride | Dutasteride | CAPSULE | ANDA |
| EPINEPHRINE | epinephrine | INJECTION | ANDA |
| EluRyng | Etonogestrel and Ethinyl Estradiol | RING | ANDA |
| Entecavir | Entecavir | TABLET, FILM COATED | ANDA |
| Entecavir | Entecavir | TABLET, FILM COATED | ANDA |
| Ephedrine Sulfate | Ephedrine Sulfate | INJECTION | ANDA |
| Escitalopram Oxalate | Escitalopram Oxalate | TABLET, FILM COATED | ANDA |
| Escitalopram Oxalate | Escitalopram Oxalate | TABLET, FILM COATED | ANDA |
| Escitalopram Oxalate | Escitalopram Oxalate | TABLET, FILM COATED | ANDA |
| Escitalopram Oxalate | Escitalopram | SOLUTION | ANDA |
| Esmolol Hydrochloride | Esmolol Hydrochloride in Sodium Chloride | INJECTION | ANDA |
| Esmolol Hydrochloride | Esmolol Hydrochloride in Sodium Chloride | INJECTION | ANDA |
| Exenatide | Exenatide | INJECTION | ANDA |
| Exenatide | Exenatide | INJECTION | ANDA |
| Extended Phenytoin Sodium | Phenytoin Sodium | CAPSULE | ANDA |
| FENOFIBRATE | FENOFIBRATE | TABLET | ANDA |
| FENOFIBRATE | FENOFIBRATE | TABLET | ANDA |
| FOCINVEZ | FOSAPREPITANT DIMEGLUMINE | INJECTION | NDA |
| FYLNETRA | pegfilgrastim | INJECTION | BLA |
| Felbamate | Felbamate | SUSPENSION | ANDA |
| Felbamate | Felbamate | TABLET | ANDA |
| Felbamate | Felbamate | TABLET | ANDA |
| Fesoterodine Fumarate | Fesoterodine Fumarate | TABLET, EXTENDED RELEASE | ANDA |
| Fesoterodine Fumarate | Fesoterodine Fumarate | TABLET, EXTENDED RELEASE | ANDA |
| Flecainide Acetate | Flecainide Acetate | TABLET | ANDA |
| Flecainide Acetate | Flecainide Acetate | TABLET | ANDA |
| Flecainide Acetate | Flecainide Acetate | TABLET | ANDA |
| Fluocinolone Acetonide | Fluocinolone Acetonide | OIL | ANDA |
| Folic Acid | Folic Acid | TABLET | ANDA |
| Foscarnet Sodium | Foscarnet Sodium | INJECTION | ANDA |
| Fosphenytoin Sodium | Fosphenytoin Sodium | INJECTION | ANDA |
| Fosphenytoin Sodium | Fosphenytoin Sodium | INJECTION | ANDA |
| Fulvestrant | Fulvestrant | INJECTION, SOLUTION | ANDA |
| Furosemide | Furosemide | INJECTION | ANDA |
| Furosemide | Furosemide | INJECTION | ANDA |
| Furosemide | Furosemide | INJECTION | ANDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.