Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071195
Company: SANDOZ

Products on ANDA 071195

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORAZEPAM	LORAZEPAM	2MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071195

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/1988	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
02/29/2024	SUPPL-28	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/04/2007	SUPPL-21	Labeling		Label is not available on this site.
03/07/2002	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
09/21/2001	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
10/31/2000	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
05/24/2000	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
05/05/1999	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/25/1997	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/11/1997	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
01/24/1994	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/15/1993	SUPPL-6	Labeling		Label is not available on this site.
03/09/1990	SUPPL-5	Labeling		Label is not available on this site.
05/18/1992	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/27/1989	SUPPL-3	Labeling		Label is not available on this site.
01/26/1989	SUPPL-2	Labeling		Label is not available on this site.
08/18/1988	SUPPL-1	Labeling		Label is not available on this site.