Application 040826
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63304-497 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 76101 | ORIG | 2023-11-02 |