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Generated: September 26, 2018

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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 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-four 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-six suppliers are listed for this compound. Additional details are available on the clindamycin hydrochloride profile page.
Summary for 065194
Tradename:CLINDAMYCIN HYDROCHLORIDE
Applicant:Epic Pharma Llc
Ingredient:clindamycin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065194
Ingredient-typeLincosamides
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 67046-085-10 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (67046-085-10)
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 065194 ANDA Contract Pharmacy Services-PA 67046-085 67046-085-20 20 CAPSULE, GELATIN COATED in 1 BLISTER PACK (67046-085-20)

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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