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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050162

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NDA 050162 describes CLEOCIN HYDROCHLORIDE, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from three suppliers. Additional details are available on the CLEOCIN HYDROCHLORIDE profile page.

The generic ingredient in CLEOCIN HYDROCHLORIDE is clindamycin hydrochloride. There are fifty-five drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the clindamycin hydrochloride profile page.
Summary for 050162
Tradename:CLEOCIN HYDROCHLORIDE
Applicant:Pharmacia And Upjohn
Ingredient:clindamycin hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 050162
Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 050162
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLEOCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 050162 NDA Pharmacia and Upjohn Company LLC 0009-0225 N 0009-0225-02
CLEOCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 050162 NDA Pharmacia and Upjohn Company LLC 0009-0331 N 0009-0331-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 300MG BASE
Approval Date:Apr 14, 1988TE:ABRLD:Yes

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