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Generated: December 16, 2018

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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, Micro Labs, Mylan Pharms Inc, Sun Pharm Inds Ltd, Teva, Watson Labs, and Zydus Pharms Usa, and is included in eleven 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 065217
Tradename:CLINDAMYCIN HYDROCHLORIDE
Applicant:Zydus Pharms Usa
Ingredient:clindamycin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065217
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 68382-234-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (68382-234-01)
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 065217 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-234 68382-234-05 500 CAPSULE, GELATIN COATED in 1 BOTTLE (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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