Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074818
Company: WATSON LABS

Products on ANDA 074818

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074818

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/19/1997	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/74818ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2023	SUPPL-28	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/05/2021	SUPPL-27	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/16/2019	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
10/14/2008	SUPPL-19	Labeling		Label is not available on this site.
08/20/2008	SUPPL-18	Labeling		Label is not available on this site.
12/04/2007	SUPPL-16	Labeling		Label is not available on this site.
04/12/2001	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
03/21/2000	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
08/21/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
03/09/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074818

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