Details for New Drug Application (NDA): 208776
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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 208776
| Tradename: | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE |
| Applicant: | Sun Pharma Canada |
| Ingredient: | benzoyl peroxide; clindamycin phosphate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208776
| 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 | 208776 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-1381 | 51672-1381-5 | 1 KIT in 1 CARTON (51672-1381-5) * 7 g in 1 BOTTLE, PLASTIC (51672-1382-3) * 28 g in 1 BOTTLE, PUMP |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 208776 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-1381 | 51672-1381-6 | 1 KIT in 1 CARTON (51672-1381-6) * 10 g in 1 BOTTLE, PLASTIC (51672-1382-2) * 40 g in 1 BOTTLE, PUMP |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 5%;EQ 1% BASE | ||||
| Approval Date: | May 25, 2018 | TE: | AB | RLD: | No | ||||
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