Application 091313
- Type
- ANDA
- Sponsor
- MAYNE PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No |
| 003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 004 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 005 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52959-130 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | H.J. Harkins Company, Inc. | ANDA | Current |
| 68308-108 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-108 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-108 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-110 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-110 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-110 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-111 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-111 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-111 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-112 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-112 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-112 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-120 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-120 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-120 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-505 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-505 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 68308-505 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76110 | ORIG | 2023-11-02 |