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Serving hundreds of leading biopharmaceutical companies globally:

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Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065217

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NDA 065217 describes CLINDAMYCIN HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Epic Pharma Llc, G And W Labs Inc, Lannett Co Inc, 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-two suppliers. Additional details are available on the CLINDAMYCIN HYDROCHLORIDE profile page.

The generic ingredient in CLINDAMYCIN HYDROCHLORIDE 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 065217
Tradename:CLINDAMYCIN HYDROCHLORIDE
Applicant:Zydus Pharms Usa
Ingredient:clindamycin hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065217
Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 065217
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 065217 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-234 N 68382-234-01
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 065217 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-234 N 68382-234-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Jan 31, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Jan 31, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 300MG BASE
Approval Date:Jan 31, 2005TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Merck
McKinsey
Harvard Business School
Moodys
Cerilliant
Citi
Queensland Health
AstraZeneca

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