Last Updated: November 8, 2026

Details for New Drug Application (NDA): 065389

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NDA 065389 describes DEMECLOCYCLINE HYDROCHLORIDE, which is a drug marketed by Amneal Pharm, Barr, Epic Pharma Llc, and Impax Labs, and is included in five NDAs. It is available from five suppliers. Additional details are available on the DEMECLOCYCLINE HYDROCHLORIDE profile page.

The generic ingredient in DEMECLOCYCLINE HYDROCHLORIDE is demeclocycline hydrochloride. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the demeclocycline hydrochloride profile page.

Summary for 065389

Tradename:	DEMECLOCYCLINE HYDROCHLORIDE
Applicant:	Epic Pharma Llc
Ingredient:	demeclocycline hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 065389

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Dec 1, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Dec 1, 2008	TE:	AB	RLD:	No

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