Details for New Drug Application (NDA): 090979
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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. Fifteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
Summary for 090979
Tradename: | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE |
Applicant: | Padagis Israel |
Ingredient: | benzoyl peroxide; clindamycin phosphate |
Patents: | 0 |
Pharmacology for NDA: 090979
Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 090979
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 | 090979 | ANDA | Medimetriks Pharmaceuticals | 43538-176 | 43538-176-45 | 1 TUBE in 1 CARTON (43538-176-45) / 45 g in 1 TUBE |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 090979 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-736 | 45802-736-84 | 1 TUBE in 1 CARTON (45802-736-84) / 45 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 5%;1.2% | ||||
Approval Date: | Jun 26, 2012 | TE: | AB | RLD: | No |
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