Application 216635
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | FOR SOLUTION;ORAL | 50MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67877-772 | Diclofenac Potassium | Diclofenac Potassium | Ascend Laboratories, LLC | ANDA | Current |