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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065131

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NDA 065131 describes MINOCYCLINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent Pharma Inc, Watson Labs, Watson Labs Teva, Zydus Worldwide, 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-five suppliers. Additional details are available on the MINOCYCLINE HYDROCHLORIDE profile page.

The generic ingredient in MINOCYCLINE HYDROCHLORIDE is minocycline hydrochloride. There are thirteen drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.

Summary for 065131

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 065131

Ingredient-typeTetracyclines

Medical Subject Heading (MeSH) Categories for 065131

Suppliers and Packaging for NDA: 065131

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET;ORAL 065131 ANDA AvKARE, Inc. 42291-589 42291-589-90 90 TABLET in 1 BOTTLE (42291-589-90)
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET;ORAL 065131 ANDA AvKARE, Inc. 42291-591 42291-591-60 60 TABLET in 1 BOTTLE (42291-591-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Apr 16, 2003TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Apr 16, 2003TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Apr 16, 2003TE:ABRLD:No


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