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Generated: April 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065485

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NDA 065485 describes MINOCYCLINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent, Watson Labs, Watson Labs Teva, Zydus, Alkem Labs Ltd, Aurobindo Pharma Ltd, Barr Labs Inc, Impax Labs Inc, Lupin Ltd, Mylan Pharms Inc, Sandoz, Sidmak Labs India, Sun Pharm Inds Ltd, Zydus Pharms Usa Inc, Dr Reddys Labs Ltd, Par Pharm, Sun Pharm Industries, and Triax Pharms, and is included in twenty-four NDAs. It is available from forty-three suppliers. Additional details are available on the MINOCYCLINE HYDROCHLORIDE profile page.

The generic ingredient in MINOCYCLINE HYDROCHLORIDE is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 065485
Tradename:MINOCYCLINE HYDROCHLORIDE
Applicant:Barr Labs Inc
Ingredient:minocycline hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065485
Medical Subject Heading (MeSH) Categories for 065485
Suppliers and Packaging for NDA: 065485
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 065485 ANDA Teva Pharmaceuticals USA, Inc. 0093-2133 0093-2133-56 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-2133-56)
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 065485 ANDA Teva Pharmaceuticals USA, Inc. 0093-2134 0093-2134-56 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-2134-56)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 45MG BASE
Approval Date:Mar 17, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 90MG BASE
Approval Date:Mar 17, 2009TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 135MG BASE
Approval Date:Mar 17, 2009TE:RLD:No

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