Application 090535
- Type
- ANDA
- Sponsor
- SUN PHARM INDS INC
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55700-658 | oxycodone and acetaminophen | oxycodone and acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-658 | oxycodone and acetaminophen | oxycodone and acetaminophen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 57664-155 | oxycodone and acetaminophen | oxycodone and acetaminophen | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-156 | oxycodone and acetaminophen | oxycodone and acetaminophen | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 57664-160 | oxycodone and acetaminophen | oxycodone and acetaminophen | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 67296-1624 | oxycodone and acetaminophen | oxycodone and acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1624 | oxycodone and acetaminophen | oxycodone and acetaminophen | RedPharm Drug, Inc. | ANDA | Current |
| 71335-0221 | oxycodone and acetaminophen | oxycodone and acetaminophen | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76092 | ORIG | 2023-11-02 |