Details for New Drug Application (NDA): 065443
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NDA 065443 describes CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, which is a drug marketed by Actavis Labs Ut Inc, Chartwell Rx, Encube, Glenmark Speclt, Mylan Pharms Inc, Padagis Israel, Sun Pharma Canada, and Zydus Pharms, and is included in sixteen NDAs. It is available from fourteen suppliers. Additional details are available on the CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE profile page.
The generic ingredient in CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE is benzoyl peroxide; clindamycin phosphate. There are seventeen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
The generic ingredient in CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE is benzoyl peroxide; clindamycin phosphate. There are seventeen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
Summary for 065443
| Tradename: | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE |
| Applicant: | Mylan Pharms Inc |
| Ingredient: | benzoyl peroxide; clindamycin phosphate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065443
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 065443 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8688 | 0378-8688-35 | 1 KIT in 1 CARTON (0378-8688-35) * 5 g in 1 BOTTLE, PLASTIC * 20 g in 1 JAR |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 065443 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8688 | 0378-8688-54 | 1 KIT in 1 CARTON (0378-8688-54) * 10 g in 1 BOTTLE, PLASTIC * 40 g in 1 JAR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 5%;EQ 1% BASE | ||||
| Approval Date: | Aug 11, 2009 | TE: | AB | RLD: | No | ||||
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