Details for New Drug Application (NDA): 090422

NDA 090422 describes MINOCYCLINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent, Watson Labs, Watson Labs Teva, Zydus, Nexus Pharms, Alkem Labs Ltd, Aurobindo Pharma Ltd, Barr Labs Inc, Chartwell Rx, Impax Labs Inc, Norvium Bioscience, Rising, Sandoz, Sun Pharm, Sun Pharm Inds Ltd, Zydus Pharms, Beximco Pharms Usa, Dr Reddys Labs Ltd, Strides Pharma, Sun Pharm Industries, and Triax Pharms, and is included in twenty-eight NDAs. It is available from twenty-eight suppliers. Additional details are available on the MINOCYCLINE HYDROCHLORIDE profile page.

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

Summary for 090422

Tradename:	MINOCYCLINE HYDROCHLORIDE
Applicant:	Sandoz
Ingredient:	minocycline hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 090422

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 45MG BASE
Approval Date:	Aug 13, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 90MG BASE
Approval Date:	Aug 13, 2009	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 135MG BASE
Approval Date:	Aug 13, 2009	TE:	AB	RLD:	No

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