Details for New Drug Application (NDA): 050782
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The generic ingredient in CLINDAGEL is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
Summary for 050782
Tradename: | CLINDAGEL |
Applicant: | Bausch |
Ingredient: | clindamycin phosphate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 050782
Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 050782
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLINDAGEL | clindamycin phosphate | GEL;TOPICAL | 050782 | NDA | Bausch Health US, LLC | 16781-462 | 16781-462-06 | 6 BOTTLE in 1 CARTON (16781-462-06) / 7.3 mL in 1 BOTTLE |
CLINDAGEL | clindamycin phosphate | GEL;TOPICAL | 050782 | NDA | Bausch Health US, LLC | 16781-462 | 16781-462-75 | 1 BOTTLE in 1 CARTON (16781-462-75) / 75 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | EQ 1% BASE | ||||
Approval Date: | Nov 27, 2000 | TE: | AB2 | RLD: | Yes |
Expired US Patents for NDA 050782
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch | CLINDAGEL | clindamycin phosphate | GEL;TOPICAL | 050782-001 | Nov 27, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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