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Serving leading biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo
Express Scripts
Cantor Fitzgerald
Federal Trade Commission

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 063011

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NDA 063011 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 063011

Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 063011


Medical Subject Heading (MeSH) Categories for 063011

Suppliers and Packaging for NDA: 063011

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride CAPSULE;ORAL 063011 ANDA Teva Pharmaceuticals USA, Inc. 0093-3165 0093-3165-01 100 CAPSULE in 1 BOTTLE (0093-3165-01)
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride CAPSULE;ORAL 063011 ANDA Cardinal Health 55154-8289 55154-8289-0 10 POUCH in 1 BAG (55154-8289-0) > 1 CAPSULE in 1 POUCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Mar 2, 1992TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
Express Scripts
Boehringer Ingelheim

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