Application 204637
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZELAIC ACID | AZELAIC ACID | GEL;TOPICAL | 15% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68462-626 | azelaic acid | azelaic acid | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-626 | azelaic acid | azelaic acid | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-626 | azelaic acid | azelaic acid | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10371 | ORIG | 2016-02-19 |