Register entryShortage reported
Par Health USA, LLC
- Registered sites
- 5
- Drug products
- 176
- Live patents
- 1
- Countries
- 2
- Base
- India
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackagingsterilize
Sites
Facilities
5| Site | Location | Operations | FEI |
|---|---|---|---|
| Par Active Technologies Private Limited | ChennaiIndia | Active ingredient (API) manufacture | 3003597293 |
| Par Formulations Private Limited | ChennaiIndia | Analytical testing, Finished drug manufacture, Packaging | 3007027193 |
| Par Formulations Private Limited | DharIndia | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3016268582 |
| Par Formulations Private Limited | Navi MumbaiIndia | Analytical testing | 3014425346 |
| Par Health USA, LLC | Rochester, MIUnited States | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 1818977 |
Alert
Products in shortage
4| Drug | Presentation | Availability |
|---|---|---|
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-186-20) | Unavailable |
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-187-10) | Unavailable |
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 42023-146-25) | Available |
| Methylprednisolone Acetate Injection | Methylprednisolone Acetate, Injection, 80 mg/1 mL (NDC 42023-240-01) | Unavailable |
Exclusivity
Patents
1Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| ANTIZOL | FOMEPIZOLE | Jun 2027 |
Catalogue
Marketed products
176Showing 150 of 176.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| ALISKIREN | ALISKIREN | TABLET, FILM COATED | ANDA |
| ALISKIREN | ALISKIREN | TABLET, FILM COATED | ANDA |
| ALVIMOPAN | ALVIMOPAN | CAPSULE | ANDA |
| Adrenalin | epinephrine | INJECTION | NDA |
| Adrenalin | epinephrine | INJECTION | NDA |
| Adrenalin (epinephrine in sodium chloride) | Epinephrine in Sodium Chloride | INJECTION | NDA |
| Adrenalin (epinephrine in sodium chloride) | Epinephrine in Sodium Chloride | INJECTION | NDA |
| Adrenalin (epinephrine in sodium chloride) | Epinephrine in Sodium Chloride | INJECTION | NDA |
| Adrenalin (epinephrine in sodium chloride) | Epinephrine in Sodium Chloride | INJECTION | NDA |
| Adrenalin (epinephrine in sodium chloride) | Epinephrine in Sodium Chloride | INJECTION | NDA |
| Allopurinol | allopurinol | TABLET | ANDA |
| Allopurinol | allopurinol | TABLET | ANDA |
| Alprazolam | alprazolam | TABLET, ORALLY DISINTEGRATING | ANDA |
| Alprazolam | alprazolam | TABLET, ORALLY DISINTEGRATING | ANDA |
| Alprazolam | alprazolam | TABLET, ORALLY DISINTEGRATING | ANDA |
| Alprazolam | alprazolam | TABLET, ORALLY DISINTEGRATING | ANDA |
| Amiloride Hydrochloride | Amiloride Hydrochloride | TABLET | ANDA |
| Argatroban | Argatroban | INJECTION | ANDA |
| Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg | Aspirin and Extended - Release Dipyridamole | CAPSULE | ANDA |
| Baclofen | Baclofen | TABLET | ANDA |
| Baclofen | Baclofen | TABLET | ANDA |
| Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride | Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride | CAPSULE | ANDA |
| Bivalirudin | Bivalirudin | INJECTION, SOLUTION | NDA |
| Brevital Sodium | methohexital sodium | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Buprenorphine Hydrochloride | Buprenorphine Hydrochloride | INJECTION | ANDA |
| CALCITONIN SALMON | CALCITONIN SALMON | SPRAY, METERED | ANDA |
| Calcitonin Salmon | Calcitonin Salmon | INJECTION, SOLUTION | ANDA |
| Cholestyramine | cholestyramine | POWDER, FOR SUSPENSION | ANDA |
| Cholestyramine | cholestyramine | POWDER, FOR SUSPENSION | ANDA |
| Clonazepam | clonazepam | TABLET, ORALLY DISINTEGRATING | ANDA |
| Clonazepam | clonazepam | TABLET, ORALLY DISINTEGRATING | ANDA |
| Clonazepam | clonazepam | TABLET, ORALLY DISINTEGRATING | ANDA |
| Clonazepam | clonazepam | TABLET, ORALLY DISINTEGRATING | ANDA |
| Clonazepam | clonazepam | TABLET, ORALLY DISINTEGRATING | ANDA |
| Colchicine | Colchicine | CAPSULE | ANDA |
| Colchicine | colchicine | TABLET, FILM COATED | ANDA |
| Coly-Mycin M | colistimethate | INJECTION | NDA |
| DOXYCYCLINE | Doxycycline | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| Dantrium | dantrolene sodium | INJECTION | NDA |
| Daptomycin | Daptomycin | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Delestrogen | estradiol valerate | INJECTION | NDA |
| Delestrogen | estradiol valerate | INJECTION | NDA |
| Dexlansoprazole | Dexlansoprazole | CAPSULE, DELAYED RELEASE | ANDA |
| Dexlansoprazole | Dexlansoprazole | CAPSULE, DELAYED RELEASE | ANDA |
| Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride | INJECTION, SOLUTION, CONCENTRATE | ANDA |
| Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride | INJECTION, SOLUTION | ANDA |
| Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride | INJECTION, SOLUTION | ANDA |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Dexmethylphenidate Hydrochloride Extended-Release | Dexmethylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Dexmethylphenidate Hydrochloride Extended-Release | Dexmethylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Diazoxide | Diazoxide | SUSPENSION | ANDA |
| Diclofenac Potassium | Diclofenac Potassium | POWDER, FOR SOLUTION | ANDA |
| ENDOCET | Oxycodone and Acetaminophen | TABLET | ANDA |
| ENDOCET | Oxycodone and Acetaminophen | TABLET | ANDA |
| ENDOCET | Oxycodone and Acetaminophen | TABLET | ANDA |
| ENDOCET | Oxycodone and Acetaminophen | TABLET | ANDA |
| EPHEDRINE SULFATE | Ephedrine Sulfate | INJECTION | NDA |
| ETHACRYNATE SODIUM | ethacrynate sodium | INJECTION, POWDER, FOR SOLUTION | ANDA |
| Ephedrine Sulfate | Ephedrine Sulfate | INJECTION, SOLUTION | NDA |
| Everolimus | Everolimus | TABLET | ANDA |
| Everolimus | Everolimus | TABLET | ANDA |
| Everolimus | Everolimus | TABLET | ANDA |
| Everolimus | Everolimus | TABLET | ANDA |
| Fluoxetine | Fluoxetine | TABLET, FILM COATED | ANDA |
| Fluvoxamine Maleate | Fluvoxamine Maleate | CAPSULE, EXTENDED RELEASE | ANDA |
| Fluvoxamine Maleate | Fluvoxamine Maleate | CAPSULE, EXTENDED RELEASE | ANDA |
| Glycerol Phenylbutyrate | Glycerol Phenylbutyrate oral | LIQUID | ANDA |
| Glycopyrrolate | Glycopyrrolate | SOLUTION | ANDA |
| Glycopyrrolate | glycopyrrolate | TABLET | ANDA |
| Glycopyrrolate | glycopyrrolate | TABLET | ANDA |
| Hydroxyurea | Hydroxyurea | CAPSULE | ANDA |
| Ibuprofen and famotidine | Ibuprofen and famotidine | TABLET | ANDA |
| Isosorbide Dinitrate | isosorbide dinitrate | TABLET | ANDA |
| Isosorbide Dinitrate | isosorbide dinitrate | TABLET | ANDA |
| Isosorbide Dinitrate | isosorbide dinitrate | TABLET | ANDA |
| Isosorbide Dinitrate | isosorbide dinitrate | TABLET | ANDA |
| Isosorbide Dinitrate | Isosorbide Dinitrate | TABLET | ANDA |
| Ketalar | ketamine hydrochloride | INJECTION | NDA |
| Ketalar | ketamine hydrochloride | INJECTION | NDA |
| Ketalar | ketamine hydrochloride | INJECTION | NDA |
| Lamotrigine | Lamotrigine | TABLET, ORALLY DISINTEGRATING | ANDA |
| Lamotrigine | Lamotrigine | TABLET, ORALLY DISINTEGRATING | ANDA |
| Lamotrigine | Lamotrigine | TABLET, ORALLY DISINTEGRATING | ANDA |
| Lamotrigine | Lamotrigine | TABLET, ORALLY DISINTEGRATING | ANDA |
| Lamotrigine | Lamotrigine | KIT | ANDA |
| Lamotrigine | Lamotrigine | KIT | ANDA |
| Lamotrigine | Lamotrigine | KIT | ANDA |
| Lamotrigine Extended Release | lamotrigine extended release | TABLET | ANDA |
| Lamotrigine Extended Release | lamotrigine extended release | TABLET | ANDA |
| Lamotrigine Extended Release | lamotrigine extended release | TABLET | ANDA |
| Lamotrigine Extended-Release | lamotrigine | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| Lamotrigine Extended-Release | lamotrigine | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| Lamotrigine Extended-Release | lamotrigine | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| Lamotrigine Extended-Release | lamotrigine | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| Lidocaine | lidocaine | PATCH | NDA AUTHORIZED GENERIC |
| Lubiprostone | Lubiprostone | CAPSULE, GELATIN COATED | NDA AUTHORIZED GENERIC |
| Lubiprostone | Lubiprostone | CAPSULE, GELATIN COATED | NDA AUTHORIZED GENERIC |
| MethylPREDNISolone | methylprednisolone | TABLET | ANDA |
| Micafungin | Micafungin | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Micafungin | Micafungin | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Minoxidil | Minoxidil | TABLET | ANDA |
| Minoxidil | Minoxidil | TABLET | ANDA |
| Mycophenolate Mofetil | mycophenolate mofetil | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | INJECTION | ANDA |
| NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | INJECTION | ANDA |
| Naloxone Hydrochloride | Naloxone Hydrochloride | INJECTION | ANDA |
| Nascobal | cyanocobalamin | SPRAY | NDA |
| Nitisinone | Nitisinone | CAPSULE | ANDA |
| Nitisinone | Nitisinone | CAPSULE | ANDA |
| Nitisinone | Nitisinone | CAPSULE | ANDA |
| Olanzapine and Fluoxetine | olanzapine and fuoxetine | CAPSULE | ANDA |
| Olanzapine and Fluoxetine | olanzapine and fuoxetine | CAPSULE | ANDA |
| Olanzapine and Fluoxetine | olanzapine and fuoxetine | CAPSULE | ANDA |
| Olanzapine and Fluoxetine | olanzapine and fuoxetine | CAPSULE | ANDA |
| Olanzapine and Fluoxetine | olanzapine and fuoxetine | CAPSULE | ANDA |
| Omega-3-acid ethyl esters | Omega-3-acid ethyl esters | CAPSULE | ANDA |
| Penicillamine | penicillamine | CAPSULE | ANDA |
| Phenobarbital | phenobarbital | TABLET | UNAPPROVED DRUG OTHER |
| Phenobarbital | phenobarbital | TABLET | UNAPPROVED DRUG OTHER |
| Phenobarbital | phenobarbital | TABLET | UNAPPROVED DRUG OTHER |
| Phenobarbital | phenobarbital | TABLET | UNAPPROVED DRUG OTHER |
| Phenylephrine hydrochloride | Phenylephrine hydrochloride | INJECTION | ANDA |
| Phenylephrine hydrochloride | Phenylephrine hydrochloride | INJECTION | ANDA |
| Pitocin | oxytocin | INJECTION | NDA |
| Pitocin | oxytocin | INJECTION | NDA |
| Posaconazole | Posaconazole | INJECTION | ANDA |
| Prednisone | Prednisone | TABLET | ANDA |
| Prednisone | Prednisone | TABLET | ANDA |
| Prednisone | Prednisone | TABLET | ANDA |
| Prednisone | Prednisone | TABLET | ANDA |
| Prednisone | Prednisone | TABLET | ANDA |
| Risperidone | Risperidone | TABLET, ORALLY DISINTEGRATING | ANDA |
| Risperidone | Risperidone | TABLET, ORALLY DISINTEGRATING | ANDA |
| Risperidone | Risperidone | TABLET, ORALLY DISINTEGRATING | ANDA |
| Risperidone | Risperidone | TABLET, ORALLY DISINTEGRATING | ANDA |
| Risperidone | Risperidone | TABLET, ORALLY DISINTEGRATING | ANDA |
| Risperidone | Risperidone | TABLET, ORALLY DISINTEGRATING | ANDA |
| SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | POWDER, FOR SOLUTION | ANDA |
| SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | POWDER, FOR SOLUTION | ANDA |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | SOLUTION | ANDA |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | SOLUTION | ANDA |
| Sitagliptin and Metformin hydrochloride | sitagliptin and metformin hydrochloride | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| Sitagliptin and Metformin hydrochloride | sitagliptin and metformin hydrochloride | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| Sitagliptin and Metformin hydrochloride | sitagliptin and metformin hydrochloride | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| Sodium Phenylbutyrate | Sodium Phenylbutyrate | POWDER | 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.