Application 208301
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | GEL;TOPICAL | 3% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50436-0355 | DICLOFENAC SODIUM | diclofenac sodium | Unit Dose Services | ANDA | Current |
| 53149-4901 | DICLOFENAC SODIUM | diclofenac sodium | All Pharma, LLC | ANDA | Current |
| 53149-4901 | DICLOFENAC SODIUM | diclofenac sodium | All Pharma, LLC | ANDA | Current |
| 55700-511 | DICLOFENAC SODIUM | diclofenac sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-511 | DICLOFENAC SODIUM | diclofenac sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-511 | DICLOFENAC SODIUM | diclofenac sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60760-095 | DICLOFENAC SODIUM | diclofenac sodium | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 68462-355 | DICLOFENAC SODIUM | diclofenac sodium | GLENMARK PHARMACEUTICALS INC., USA | ANDA | Current |
| 68462-355 | DICLOFENAC SODIUM | diclofenac sodium | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-355 | DICLOFENAC SODIUM | diclofenac sodium | GLENMARK PHARMACEUTICALS INC., USA | ANDA | Current |
| 68462-355 | DICLOFENAC SODIUM | diclofenac sodium | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68788-9435 | DICLOFENAC SODIUM | diclofenac sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9435 | DICLOFENAC SODIUM | diclofenac sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9435 | DICLOFENAC SODIUM | diclofenac sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9435 | DICLOFENAC SODIUM | diclofenac sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9435 | DICLOFENAC SODIUM | diclofenac sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-3315 | DICLOFENAC SODIUM | diclofenac sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-3315 | DICLOFENAC SODIUM | diclofenac sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-3315 | DICLOFENAC SODIUM | diclofenac sodium | REMEDYREPACK INC. | ANDA | Current |
| 72189-379 | Diclofenac Sodium Gel | Diclofenac Sodium Gel | Direct_Rx | ANDA | Current |
| 72189-379 | Diclofenac Sodium Gel | Diclofenac Sodium Gel | Direct_Rx | ANDA | Current |
| 76420-132 | DICLOFENAC SODIUM | diclofenac sodium | Asclemed USA, Inc. | ANDA | Current |