Details for New Drug Application (NDA): 204459
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NDA 204459 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 204459
| Tradename: | OXYMORPHONE HYDROCHLORIDE |
| Applicant: | Aurolife Pharma Llc |
| Ingredient: | oxymorphone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 204459
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 204459
Suppliers and Packaging for NDA: 204459
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET;ORAL | 204459 | ANDA | Aurolife Pharma, LLC | 13107-103 | 13107-103-01 | 100 TABLET in 1 BOTTLE (13107-103-01) |
| OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET;ORAL | 204459 | ANDA | Aurolife Pharma, LLC | 13107-103 | 13107-103-30 | 30 TABLET in 1 BOTTLE (13107-103-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Apr 26, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 26, 2016 | TE: | AB | RLD: | No | ||||
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