Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074909
Company: SANDOZ

Products on ANDA 074909

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074909

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/25/1998	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74909ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/31/2019	SUPPL-25	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/29/2012	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
10/31/2014	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
02/28/2008	SUPPL-17	Labeling		Label is not available on this site.
12/09/2002	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
03/18/2002	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
03/18/2002	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
04/19/2002	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
11/19/2001	SUPPL-7	Labeling		Label is not available on this site.
10/10/2001	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
02/16/2001	SUPPL-5	Labeling		Label is not available on this site.
02/01/2000	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
11/15/1999	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
08/06/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074909

ALPRAZOLAM

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET;ORAL	Prescription	No	AB	074342	ACTAVIS ELIZABETH
ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET;ORAL	Prescription	No	AB	203346	AUROBINDO PHARMA
ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET;ORAL	Prescription	No	AB	200739	NATCO
ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET;ORAL	Prescription	No	AB	074174	NOVITIUM PHARMA
ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET;ORAL	Prescription	No	AB	074909	SANDOZ
XANAX	ALPRAZOLAM	2MG	TABLET;ORAL	Prescription	Yes	AB	018276	UPJOHN