Application 203208
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | SOLUTION;ORAL | 100MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0393 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0393 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0522 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Roxane Laboratories, Inc. | ANDA | Current |
| 17856-0393 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Atlantic Biologicals Corps | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76210 | ORIG | 2023-11-03 |