Details for New Drug Application (NDA): 209252
NDA 209252 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 seventeen NDAs. It is available from twelve 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 is one drug master file entry 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 is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
Summary for 209252
| Tradename: | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE |
| Applicant: | Glenmark Speclt |
| Ingredient: | benzoyl peroxide; clindamycin phosphate |
| Patents: | 0 |
Pharmacology for NDA: 209252
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 209252
| 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 | 209252 | ANDA | NorthStar RxLLC | 16714-984 | 16714-984-25 | 1 JAR in 1 CARTON (16714-984-25) / 25 g in 1 JAR |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 209252 | ANDA | NorthStar RxLLC | 16714-984 | 16714-984-50 | 1 JAR in 1 CARTON (16714-984-50) / 50 g in 1 JAR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 5%;EQ 1% BASE | ||||
| Approval Date: | Mar 14, 2019 | TE: | AB | RLD: | No | ||||
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