Register entry
Endo USA, Inc.
- Registered sites
- 3
- Drug products
- 67
- Live patents
- 38
- Countries
- 1
- Base
- United States
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
3| Site | Location | Operations | FEI |
|---|---|---|---|
| Endo USA, Inc. | Cranbury, NJUnited States | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 2243842 |
| Endo USA, Inc. | Horsham, PAUnited States | Analytical testing, Active ingredient (API) manufacture | 3006537159 |
| Endo USA, Inc. | Rye, NYUnited States | Finished drug manufacture, sterilize | 2410861 |
Exclusivity
Patents
38Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| AVEED | TESTOSTERONE UNDECANOATE | Mar 2027 |
| AVEED | TESTOSTERONE UNDECANOATE | May 2027 |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | Jun 2027 |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | Jul 2029 |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | Nov 2029 |
| SUMAVEL DOSEPRO | SUMATRIPTAN SUCCINATE | Nov 2026 |
Catalogue
Marketed products
67Showing 67 of 67.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Aveed | testosterone undecanoate | INJECTION | NDA |
| Benztropine Mesylate | benztropine mesylate | TABLET | ANDA |
| Benztropine Mesylate | benztropine mesylate | TABLET | ANDA |
| Benztropine Mesylate | benztropine mesylate | TABLET | ANDA |
| Chlorzoxazone | Chlorzoxazone | TABLET | ANDA |
| Chlorzoxazone | Chlorzoxazone | TABLET | ANDA |
| Cortisporin TC | colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate | SUSPENSION | NDA |
| Dantrium | dantrolene sodium | CAPSULE | NDA |
| Doxylamine Succinate and Pyridoxine Hydrochloride | Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg | TABLET, DELAYED RELEASE | ANDA |
| ERTAPENEM | ertapenem sodium | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Edex | alprostadil | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Edex | alprostadil | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Edex | alprostadil | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Felodipine | Felodipine | TABLET, EXTENDED RELEASE | ANDA |
| Felodipine | Felodipine | TABLET, EXTENDED RELEASE | ANDA |
| Felodipine | Felodipine | TABLET, FILM COATED, EXTENDED RELEASE | ANDA |
| Ganciclovir | Ganciclovir | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA |
| LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | INJECTION | ANDA |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Magnesium Oxide | Magnesium Oxide | TABLET | OTC MONOGRAPH DRUG |
| Magnesium Oxide | Magnesium Oxide | TABLET | OTC MONOGRAPH DRUG |
| Midodrine Hydrochloride | Midodrine Hydrochloride | TABLET | ANDA |
| Midodrine Hydrochloride | Midodrine Hydrochloride | TABLET | ANDA |
| Midodrine Hydrochloride | Midodrine Hydrochloride | TABLET | ANDA |
| POSACONAZOLE | posaconazole | SUSPENSION | NDA AUTHORIZED GENERIC |
| POSACONAZOLE | posaconazole | TABLET, COATED | NDA AUTHORIZED GENERIC |
| PRAZIQUANTEL | PRAZIQUANTEL | TABLET, FILM COATED | ANDA |
| PREVDUO | neostigmine methylsulfate and glycopyrrolate | INJECTION | NDA |
| Perphenazine | perphenazine | TABLET, FILM COATED | ANDA |
| Perphenazine | perphenazine | TABLET, FILM COATED | ANDA |
| Perphenazine | perphenazine | TABLET, FILM COATED | ANDA |
| Perphenazine | perphenazine | TABLET, FILM COATED | ANDA |
| Pimozide | Pimozide | TABLET | ANDA |
| Pimozide | Pimozide | TABLET | ANDA |
| Potassium Chloride | Potassium Chloride | SOLUTION | NDA |
| Potassium Chloride | Potassium Chloride | POWDER, FOR SOLUTION | NDA |
| Propranolol Hydrochloride | propranolol hydrochloride | TABLET | ANDA |
| Propranolol Hydrochloride | propranolol hydrochloride | TABLET | ANDA |
| Propranolol Hydrochloride | propranolol hydrochloride | TABLET | ANDA |
| Propranolol Hydrochloride | propranolol hydrochloride | TABLET | ANDA |
| Propranolol Hydrochloride | propranolol hydrochloride | TABLET | ANDA |
| Propylthiouracil | Propylthiouracil | TABLET | NDA |
| QUESTRAN | Cholestyramine | POWDER, FOR SUSPENSION | ANDA |
| QUESTRAN | Cholestyramine | POWDER, FOR SUSPENSION | ANDA |
| SUPPRELIN LA | histrelin acetate | IMPLANT | NDA |
| TIOPRONIN | TIOPRONIN | TABLET, DELAYED RELEASE | ANDA |
| TIOPRONIN | TIOPRONIN | TABLET, DELAYED RELEASE | ANDA |
| Testim | testosterone | GEL | NDA |
| Testopel | testosterone | PELLET | ANDA |
| Theo-24 | theophylline anhydrous | CAPSULE, EXTENDED RELEASE | ANDA |
| Theo-24 | theophylline anhydrous | CAPSULE, EXTENDED RELEASE | ANDA |
| Theo-24 | theophylline anhydrous | CAPSULE, EXTENDED RELEASE | ANDA |
| Theo-24 | theophylline anhydrous | CAPSULE, EXTENDED RELEASE | ANDA |
| Tolvaptan | Tolvaptan | TABLET | ANDA |
| Tolvaptan | Tolvaptan | TABLET | ANDA |
| Topiramate | Topiramate | CAPSULE, EXTENDED RELEASE | ANDA |
| Topiramate | Topiramate | CAPSULE, EXTENDED RELEASE | ANDA |
| Topiramate | Topiramate | CAPSULE, EXTENDED RELEASE | ANDA |
| Topiramate | Topiramate | CAPSULE, EXTENDED RELEASE | ANDA |
| Valstar | valrubicin | SOLUTION, CONCENTRATE | NDA |
| XIAFLEX | collagenase clostridium histolyticum | KIT | BLA |
| butalbital and acetaminophen | butalbital and acetaminophen | TABLET | ANDA |
| dantrolene sodium | dantrolene sodium | CAPSULE | NDA AUTHORIZED GENERIC |
| dantrolene sodium | dantrolene sodium | CAPSULE | NDA AUTHORIZED GENERIC |
| dantrolene sodium | dantrolene sodium | CAPSULE | NDA AUTHORIZED GENERIC |
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.