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Details for New Drug Application (NDA): 205128
» See Plans and Pricing
NDA 205128 describes CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, which is a drug marketed by Actavis Labs Ut Inc, Anda Repository, Glenmark Pharms, Mylan Pharms Inc, Perrigo Israel, Perrigo Uk Finco, Taro, Taro Pharms, Tolmar, and Zydus Pharms, and is included in fourteen NDAs. It is available from ten 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
Summary for 205128
| Tradename: | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE |
| Applicant: | Actavis Labs Ut Inc |
| Ingredient: | benzoyl peroxide; clindamycin phosphate |
| Patents: | 0 |
Pharmacology for NDA: 205128
| Physiological Effect | Decreased Sebaceous Gland Activity |
Suppliers and Packaging for NDA: 205128
| 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 | 205128 | ANDA | Actavis Pharma, Inc. | 0591-3916 | 0591-3916-68 | 1 BOTTLE, PUMP in 1 CARTON (0591-3916-68) > 50 g in 1 BOTTLE, PUMP |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 2.5%;EQ 1.2% BASE | ||||
| Approval Date: | Jun 19, 2015 | TE: | AB | RLD: | No | ||||
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