Application 076152
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-0355 | Diclofenac Sodium | Diclofenac Sodium | Mylan Pharmaceuticals Inc | ANDA | Current |
| 43063-270 | Diclofenac Sodium | Diclofenac Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55700-604 | Diclofenac Sodium | Diclofenac Sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-604 | Diclofenac Sodium | Diclofenac Sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |