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Generated: May 25, 2017

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Details for New Drug Application (NDA): 050615

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NDA 050615 describes CLEOCIN T, which is a drug marketed by Pharmacia And Upjohn and is included in four NDAs. It is available from three suppliers. Additional details are available on the CLEOCIN T profile page.

The generic ingredient in CLEOCIN T is clindamycin phosphate. There are fifty-two drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

Summary for NDA: 050615

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050615

Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 050615

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
clindamycin phosphate
GEL;TOPICAL 050615 NDA Pharmacia and Upjohn Company LLC 0009-3331 0009-3331-01 1 TUBE in 1 CARTON (0009-3331-01) > 60 g in 1 TUBE
clindamycin phosphate
GEL;TOPICAL 050615 NDA Pharmacia and Upjohn Company LLC 0009-3331 0009-3331-02 1 TUBE in 1 CARTON (0009-3331-02) > 30 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrengthEQ 1% BASE
Approval Date:Jan 7, 1987TE:ABRLD:Yes

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