Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019080
Company: ABBOTT

• Other Important Information from FDA

Products on NDA 019080

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROSOM	ESTAZOLAM	1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
PROSOM	ESTAZOLAM	2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019080

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/26/1990	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/06/2003	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
06/04/2004	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19080slr007ltr.pdf
05/08/1998	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/13/1993	SUPPL-5	Labeling		Label is not available on this site.
03/10/1998	SUPPL-4	Manufacturing (CMC)-Formulation		Label is not available on this site.
11/24/1992	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/05/1991	SUPPL-2	Labeling		Label is not available on this site.