Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074921
Company: DR REDDYS LABS SA

• Medication Guide

Products on ANDA 074921

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTAZOLAM	ESTAZOLAM	1MG	TABLET;ORAL	Prescription	AB	No	No
ESTAZOLAM	ESTAZOLAM	2MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074921

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/1997	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2023	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
02/05/2021	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
02/06/2019	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/20/2008	SUPPL-12	Labeling		Label is not available on this site.
01/08/2009	SUPPL-11	Labeling		Label is not available on this site.
11/08/2002	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
07/07/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 074921

ESTAZOLAM

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTAZOLAM	ESTAZOLAM	1MG	TABLET;ORAL	Prescription	No	AB	074921	DR REDDYS LABS SA
ESTAZOLAM	ESTAZOLAM	1MG	TABLET;ORAL	Prescription	No	AB	074826	NOVITIUM PHARMA
ESTAZOLAM	ESTAZOLAM	1MG	TABLET;ORAL	Prescription	No	AB	074818	WATSON LABS

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESTAZOLAM	ESTAZOLAM	2MG	TABLET;ORAL	Prescription	No	AB	074921	DR REDDYS LABS SA
ESTAZOLAM	ESTAZOLAM	2MG	TABLET;ORAL	Prescription	No	AB	074826	NOVITIUM PHARMA
ESTAZOLAM	ESTAZOLAM	2MG	TABLET;ORAL	Prescription	No	AB	074818	WATSON LABS