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Last Updated: March 25, 2026

Details for New Drug Application (NDA): 091424

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NDA 091424 describes MINOCYCLINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent, Watson Labs, Watson Labs Teva, Zydus, Alkem Labs Ltd, Aurobindo Pharma Ltd, Barr Labs Inc, Chartwell Rx, Impax Labs Inc, Pharmobedient, Rising, Sandoz, Sun Pharm, Sun Pharm Inds Ltd, Zydus Pharms, Regcon Holdings, Strides Pharma Intl, Sun Pharm Industries, and Triax Pharms, and is included in twenty-seven NDAs. It is available from twenty-one 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. Twenty-four suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.

Summary for 091424

Tradename:	MINOCYCLINE HYDROCHLORIDE
Applicant:	Chartwell Rx
Ingredient:	minocycline hydrochloride
Patents:	0

Pharmacology for NDA: 091424

Physiological Effect	Decreased Prothrombin Activity

Medical Subject Heading (MeSH) Categories for 091424

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 45MG BASE
Approval Date:	Nov 30, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 55MG BASE
Approval Date:	Nov 30, 2011	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 90MG BASE
Approval Date:	Nov 30, 2011	TE:	AB	RLD:	No

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