BioPharmaceutical Business Intelligence

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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Argus Health
Harvard Business School
US Army
Cantor Fitzgerald

Generated: September 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 063065

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NDA 063065 describes MINOCYCLINE HYDROCHLORIDE, which is a drug marketed by Impax Labs, Zydus Worldwide, Mylan Pharms Inc, Sun Pharm Inds, Sun Pharm Inds Ltd, Sandoz, Impax Labs Inc, Lupin Ltd, Par Pharm, Dr Reddys Labs Ltd, Triax Pharms, Alkem Labs Ltd, Torrent Pharma Inc, Aurobindo Pharma Ltd, Watson Labs, Sun Pharm Inds Inc, Aurobindo Pharma, Watson Labs Teva, Barr Labs Inc, and Sidmak Labs India, and is included in twenty-three NDAs. It is available from forty-two 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. Forty-nine suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.

Summary for NDA: 063065

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

Pharmacology for NDA: 063065


Suppliers and Packaging for NDA: 063065

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
minocycline hydrochloride
CAPSULE;ORAL 063065 ANDA Actavis Pharma, Inc. 0591-3153 0591-3153-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0591-3153-01)
minocycline hydrochloride
CAPSULE;ORAL 063065 ANDA Actavis Pharma, Inc. 0591-5695 0591-5695-50 50 CAPSULE in 1 BOTTLE, PLASTIC (0591-5695-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Dec 30, 1991TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Jun 10, 1999TE:ABRLD:No

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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Farmers Insurance
US Army
Federal Trade Commission
Argus Health
Harvard Business School
Boehringer Ingelheim

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