Application 050741
- Type
- NDA
- Sponsor
- STIEFEL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DUAC | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | GEL;TOPICAL | 5%;1.2% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0145-2371 | DUAC | clindamycin phosphate and benzoyl peroxide | Stiefel Laboratories Inc | NDA | Current |
| 0145-2371 | DUAC | clindamycin phosphate and benzoyl peroxide | Stiefel Laboratories Inc | NDA | Current |
| 66993-949 | Clindamycin - Benzoyl Peroxide | clindamycin phosphate and benzoyl peroxide | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-949 | Clindamycin - Benzoyl Peroxide | clindamycin phosphate and benzoyl peroxide | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-949 | Clindamycin - Benzoyl Peroxide | clindamycin phosphate and benzoyl peroxide | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30421 | SUPPL | 2015-04-17 |
| 39227 | SUPPL | 2015-04-16 |
| 30420 | SUPPL | 2013-12-31 |
| 39226 | SUPPL | 2013-12-30 |
| 8157 | SUPPL | 2013-06-11 |
| 8156 | SUPPL | 2011-12-28 |
| 39225 | SUPPL | 2011-12-23 |
| 8155 | SUPPL | 2010-11-10 |
| 18153 | SUPPL | 2010-11-08 |
| 30419 | SUPPL | 2008-07-24 |
| 39224 | SUPPL | 2008-07-23 |
| 39223 | SUPPL | 2003-12-02 |
| 30418 | SUPPL | 2003-11-25 |
| 39222 | SUPPL | 2003-10-27 |
| 8154 | SUPPL | 2003-10-24 |
| 42712 | ORIG | 2003-04-28 |
| 18152 | ORIG | 2003-04-28 |
| 8153 | ORIG | 2003-04-28 |