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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Farmers Insurance
Daiichi Sankyo

Generated: May 24, 2018

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-six 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-five suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 063011
Applicant:Zydus Worldwide
Ingredient:minocycline hydrochloride
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 Cardinal Health 55154-8289 E 55154-8289-0
MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride CAPSULE;ORAL 063011 ANDA Cardinal Health 55154-8289 E 55154-8289-4

Profile 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 hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Harvard Business School
Chinese Patent Office
Farmers Insurance
Federal Trade Commission

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