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US Army
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Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 063083

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NDA 063083 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-five 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-seven suppliers are listed for this compound. Additional details are available on the clindamycin hydrochloride profile page.
Summary for 063083
Tradename:CLINDAMYCIN HYDROCHLORIDE
Applicant:Watson Labs
Ingredient:clindamycin hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 063083
Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 063083
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 063083 ANDA KAISER FOUNDATION HOSPITALS 0179-0146 0179-0146-88 600 CAPSULE in 1 BOTTLE (0179-0146-88)
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 063083 ANDA KAISER FOUNDATION HOSPITALS 0179-0147 0179-0147-88 600 CAPSULE in 1 BOTTLE (0179-0147-88)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Jul 31, 1991TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 300MG BASE
Approval Date:Mar 18, 2003TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Medtronic
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