Application 200535
- Type
- NDA
- Sponsor
- GENUS LIFESCIENCES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | SOLUTION;ORAL | 100MG/5ML | Yes | Yes |
| 002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | SOLUTION;ORAL | 5MG/5ML | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 48433-347 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Safecor Health, LLC | NDA AUTHORIZED GENERIC | Current |
| 48433-347 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Safecor Health, LLC | NDA AUTHORIZED GENERIC | Current |
| 48433-347 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Safecor Health, LLC | NDA AUTHORIZED GENERIC | Current |
| 64950-353 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-353 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-353 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-353 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-353 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-353 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-354 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-354 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-354 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-354 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-354 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-354 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 68462-347 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Glenmark Pharmaceuticals, Inc | NDA AUTHORIZED GENERIC | Current |