Application 202076
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 325MG;37.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67877-322 | Tramadol HCl and Acetaminophen | Tramadol HCl and Acetaminophen | Ascend Laboratories, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76327 | ORIG | 2023-11-03 |