Details for New Drug Application (NDA): 205397
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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. Fourteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
Summary for 205397
Tradename: | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE |
Applicant: | Padagis Israel |
Ingredient: | benzoyl peroxide; clindamycin phosphate |
Patents: | 0 |
Pharmacology for NDA: 205397
Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 205397
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 | 205397 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-597 | 45802-597-01 | 1 BOTTLE, PUMP in 1 CARTON (45802-597-01) / 50 g in 1 BOTTLE, PUMP |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 205397 | ANDA | Bryant Ranch Prepack | 63629-8635 | 63629-8635-1 | 1 BOTTLE, PUMP in 1 CARTON (63629-8635-1) / 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: | Sep 9, 2019 | TE: | AB | RLD: | No |
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