Application 077015
- Type
- ANDA
- Sponsor
- FOUGERA PHARMS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SULFACETAMIDE SODIUM | SULFACETAMIDE SODIUM | LOTION;TOPICAL | 10% | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0168-0382 | Sulfacetamide Sodium | Sulfacetamide Sodium | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 31186 | ORIG | 2006-12-04 |