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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 091118

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NDA 091118 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-three 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-six suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.

Summary for 091118

Tradename:	MINOCYCLINE HYDROCHLORIDE
Applicant:	Sun Pharm Inds Ltd
Ingredient:	minocycline hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 091118

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 45MG BASE
Approval Date:	Sep 25, 2014	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 65MG BASE
Approval Date:	Dec 3, 2019	TE:		RLD:	No

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 80MG BASE
Approval Date:	Sep 25, 2014	TE:		RLD:	No

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