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Generated: May 21, 2018

DrugPatentWatch Database Preview

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. Ten 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
Therapeutic Class:Antibacterials
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 N 0009-3116-01
CLEOCIN T clindamycin phosphate SOLUTION;TOPICAL 050537 NDA Pharmacia and Upjohn Company LLC 0009-3116 N 0009-3116-02

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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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Fuji
QuintilesIMS
US Army
Harvard Business School
Baxter
Farmers Insurance
Dow
Johnson and Johnson

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