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Details for New Drug Application (NDA): 091118

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NDA 091118 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, Barr Labs Inc, and Sidmak Labs India, and is included in twenty-three NDAs. It is available from forty 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-six suppliers are listed for this compound. There are fifteen tentative approvals for this compound. Additional details are available on the minocycline hydrochloride profile page.

Summary for NDA: 091118

Tradename:
MINOCYCLINE HYDROCHLORIDE
Applicant:
Sun Pharm Inds Ltd
Ingredient:
minocycline hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 45MG BASE
Approval Date:Sep 25, 2014TE:ABRLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 80MG BASE
Approval Date:Sep 25, 2014TE:ABRLD:No

Summary for product number 005

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 90MG BASE
Approval Date:Sep 25, 2014TE:ABRLD:No


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