Application 064159
- Type
- ANDA
- Sponsor
- FOUGERA PHARMS INC
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | SOLUTION;TOPICAL | EQ 1% BASE | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0168-0201 | clindamycin phosphate | clindamycin phosphate | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0201 | clindamycin phosphate | clindamycin phosphate | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0201 | clindamycin phosphate | clindamycin phosphate | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0201 | clindamycin phosphate | clindamycin phosphate | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 21695-888 | Clindamycin Phosphate | Clindamycin Phosphate | Rebel Distributors Corp | ANDA | Current |
Documents
| Document | Title | Submission type | Submission no. | Date | Storage |
|---|
| 42786 | 0 | ORIG | 1 | 2005-07-22 | FDA source fallback |