Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203553
Company: ZYDUS PHARMS

Products on ANDA 203553

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203553

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/2023	ORIG-2	Approval				Label is not available on this site.
11/16/2017	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203553Orig1s000ApprovandTAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/31/2025	SUPPL-1	Labeling-Package Insert		Label is not available on this site.