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Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 063029

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NDA 063029 describes CLINDAMYCIN HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Epic Pharma Llc, G And W Labs Inc, Lannett, Mylan Pharms Inc, Sun Pharm Inds Ltd, Teva, Watson Labs, and Zydus Pharms Usa, and is included in ten NDAs. It is available from forty-three suppliers. Additional details are available on the CLINDAMYCIN HYDROCHLORIDE profile page.

The generic ingredient in CLINDAMYCIN HYDROCHLORIDE is clindamycin hydrochloride. There are fifty-four 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 063029
Tradename:CLINDAMYCIN HYDROCHLORIDE
Applicant:G And W Labs Inc
Ingredient:clindamycin hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 063029
Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 063029
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 063029 ANDA G&W Laboratories, Inc. 0713-3171 N 0713-3171-01
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 063029 ANDA G&W Laboratories, Inc. 0713-5256 N 0713-5256-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Sep 20, 1989TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 300MG BASE
Approval Date:Aug 5, 2005TE:ABRLD:No

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