Application 211708
- Type
- ANDA
- Sponsor
- GRANULES PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;2.5MG | No | No |
| 002 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;5MG | No | No |
| 003 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;7.5MG | No | No |
| 004 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70010-667 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-668 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-669 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-670 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen | Granules Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76450 | ORIG | 2023-11-07 |