Application 050793
- Type
- NDA
- Sponsor
- PERRIGO PHARMA INTL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CLINDESSE | CLINDAMYCIN PHOSPHATE | CREAM;VAGINAL | EQ 2% BASE | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 45802-042 | Clindesse | clindamycin phosphate | Padagis Israel Pharmaceuticals Ltd | NDA | Current |
| 45802-042 | Clindesse | clindamycin phosphate | Perrigo New York Inc | NDA | Current |
| 45802-042 | Clindesse | clindamycin phosphate | Perrigo New York Inc | NDA | Current |
| 45802-042 | Clindesse | clindamycin phosphate | Perrigo New York Inc | NDA | Current |
| 64011-124 | Clindesse | clindamycin phosphate | Ther-Rx Corporation | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81080 | SUPPL | 2025-02-06 |
| 80992 | SUPPL | 2025-02-05 |
| 76390 | SUPPL | 2023-11-06 |
| 76379 | SUPPL | 2023-11-06 |
| 8301 | SUPPL | 2012-02-23 |
| 39343 | SUPPL | 2012-02-17 |
| 30565 | SUPPL | 2010-12-21 |
| 39342 | SUPPL | 2010-12-16 |
| 42741 | ORIG | 2006-09-26 |
| 30564 | ORIG | 2004-12-06 |
| 18264 | ORIG | 2004-12-03 |