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Generated: November 20, 2018

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Details for New Drug Application (NDA): 050537

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NDA 050537 describes CLEOCIN, which is a drug marketed by Pharmacia And Upjohn and is included in fourteen NDAs. It is available from three suppliers. There is one patent protecting this drug. Additional details are available on the CLEOCIN profile page.

The generic ingredient in CLEOCIN is clindamycin palmitate hydrochloride. There are fifty-five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the clindamycin palmitate hydrochloride profile page.
Summary for 050537
Tradename:CLEOCIN
Applicant:Pharmacia And Upjohn
Ingredient:clindamycin phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050537
Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 050537
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLEOCIN T clindamycin phosphate SOLUTION;TOPICAL 050537 NDA Pharmacia and Upjohn Company LLC 0009-3116 0009-3116-01 1 BOTTLE in 1 CARTON (0009-3116-01) > 30 mL in 1 BOTTLE
CLEOCIN T clindamycin phosphate SOLUTION;TOPICAL 050537 NDA Pharmacia and Upjohn Company LLC 0009-3116 0009-3116-02 1 BOTTLE in 1 CARTON (0009-3116-02) > 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrengthEQ 1% BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SWAB;TOPICALStrengthEQ 1% BASE
Approval Date:Feb 22, 1994TE:ATRLD:Yes

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