Details for New Drug Application (NDA): 208683
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NDA 208683 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, Taro, and Zydus Pharms, and is included in sixteen NDAs. It is available from thirteen 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. Fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
Summary for 208683
| Tradename: | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE |
| Applicant: | Taro |
| Ingredient: | benzoyl peroxide; clindamycin phosphate |
| Patents: | 0 |
Pharmacology for NDA: 208683
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 208683
| 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 | 208683 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-1403 | 51672-1403-4 | 50 g in 1 BOTTLE, PUMP (51672-1403-4) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 3.75%;EQ 1.2% BASE | ||||
| Approval Date: | Jun 5, 2018 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 30, 2024 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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