Details for New Drug Application (NDA): 079087
✉ Email this page to a colleague
NDA 079087 describes OXYMORPHONE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Hikma, Impax Labs, Par Pharm, Specgx Llc, Sun Pharm Inds Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Avanthi Inc, Epic Pharma Llc, and Teva, and is included in thirteen NDAs. It is available from nine suppliers. Additional details are available on the OXYMORPHONE HYDROCHLORIDE profile page.
The generic ingredient in OXYMORPHONE HYDROCHLORIDE is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.
The generic ingredient in OXYMORPHONE HYDROCHLORIDE is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.
Summary for 079087
| Tradename: | OXYMORPHONE HYDROCHLORIDE |
| Applicant: | Impax Labs |
| Ingredient: | oxymorphone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 079087
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 079087
Suppliers and Packaging for NDA: 079087
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079087 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1231 | 0115-1231-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1231-01) |
| OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079087 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1231 | 0115-1231-03 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1231-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
| Approval Date: | Jun 14, 2010 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 7.5MG | ||||
| Approval Date: | Dec 21, 2010 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Jun 14, 2010 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
