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Details for New Drug Application (NDA): 065442

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NDA 065442 describes CLINDAMYCIN HYDROCHLORIDE, which is a drug marketed by Zydus Pharms Usa, Mylan Pharms Inc, Teva, G And W Labs Inc, Aurobindo Pharma, Lannett, Sun Pharm Inds Ltd, Watson Labs, and Corepharma, and is included in eleven NDAs. It is available from thirty-nine suppliers. Additional details are available on the CLINDAMYCIN HYDROCHLORIDE profile page.

The generic ingredient in CLINDAMYCIN HYDROCHLORIDE is clindamycin hydrochloride. There are fifty-two drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the clindamycin hydrochloride profile page.

Summary for NDA: 065442

Tradename:
CLINDAMYCIN HYDROCHLORIDE
Applicant:
Aurobindo Pharma
Ingredient:
clindamycin hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065442

Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 065442

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN HYDROCHLORIDE
clindamycin hydrochloride
CAPSULE;ORAL 065442 ANDA Mylan Institutional Inc. 42292-018 42292-018-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE (42292-018-20) > 1 CAPSULE in 1 BLISTER PACK (42292-018-01)
CLINDAMYCIN HYDROCHLORIDE
clindamycin hydrochloride
CAPSULE;ORAL 065442 ANDA Medsource Pharmaceuticals 45865-615 45865-615-49 100 CAPSULE in 1 BOTTLE (45865-615-49)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Aug 26, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 300MG BASE
Approval Date:Aug 26, 2009TE:ABRLD:No


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