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Generated: January 19, 2019

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Details for New Drug Application (NDA): 065243

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NDA 065243 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 065243
Tradename:CLINDAMYCIN HYDROCHLORIDE
Applicant:Lannett Co Inc
Ingredient:clindamycin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065243
Suppliers and Packaging for NDA: 065243
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 065243 ANDA Lannett Company, Inc. 0527-1383 0527-1383-01 100 CAPSULE in 1 BOTTLE (0527-1383-01)
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride CAPSULE;ORAL 065243 ANDA Lannett Company, Inc. 0527-1383 0527-1383-02 16 CAPSULE in 1 BOTTLE (0527-1383-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 300MG BASE
Approval Date:Aug 12, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Aug 12, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Aug 12, 2005TE:ABRLD:No

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