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Serving leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Fish and Richardson
Queensland Health

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065442

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NDA 065442 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-two suppliers. Additional details are available on the CLINDAMYCIN HYDROCHLORIDE profile page.

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

Summary for 065442

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065442

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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Serving leading biopharmaceutical companies globally:

Harvard Business School
US Army

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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