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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065243

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NDA 065243 describes CLINDAMYCIN HYDROCLHORIDE, which is a drug marketed by Lannett Co Inc and is included in one NDA. It is available from eight suppliers. Additional details are available on the CLINDAMYCIN HYDROCLHORIDE profile page.

The generic ingredient in CLINDAMYCIN HYDROCLHORIDE is clindamycin hydrochloride. There are fifty-five drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the clindamycin hydrochloride profile page.
Summary for 065243
Tradename:CLINDAMYCIN HYDROCLHORIDE
Applicant:Lannett Co Inc
Ingredient:clindamycin hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065243
Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 065243
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 065243 ANDA Lannett Company, Inc. 0527-1383 N 0527-1383-01
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 065243 ANDA Lannett Company, Inc. 0527-1383 N 0527-1383-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 300MG BASE
Approval Date:Aug 12, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Aug 12, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Aug 12, 2005TE:ABRLD:No

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