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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Daiichi Sankyo
Fish and Richardson

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065194

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NDA 065194 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 065194
Applicant:Epic Pharma Llc
Ingredient:clindamycin hydrochloride
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065194
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 065194
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 065194 ANDA Contract Pharmacy Services-PA 67046-085 E 67046-085-28
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 065194 ANDA Contract Pharmacy Services-PA 67046-085 E 67046-085-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Mar 22, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 300MG BASE
Approval Date:Mar 22, 2004TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
Johnson and Johnson
Queensland Health

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