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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074342
Company: ACTAVIS ELIZABETH

Products on ANDA 074342

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET;ORAL	Prescription	AB	No	No
ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET;ORAL	Prescription	AB	No	No
ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET;ORAL	Prescription	AB	No	No
ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074342

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/1993	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
12/31/2019	SUPPL-47	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/08/2011	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
05/16/2003	SUPPL-16	Labeling		Label is not available on this site.
02/15/2002	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
11/02/2001	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
04/30/2001	SUPPL-12	Labeling		Label is not available on this site.
01/24/2001	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
03/08/2000	SUPPL-10	Labeling		Label is not available on this site.
11/15/1999	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
11/15/1999	SUPPL-8	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
01/27/1998	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/05/1997	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/01/1997	SUPPL-5	Labeling		Label is not available on this site.
12/12/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/18/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/01/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074342

ALPRAZOLAM

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET;ORAL	Prescription	No	AB	074342	ACTAVIS ELIZABETH
ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET;ORAL	Prescription	No	AB	077741	APOTEX INC
ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET;ORAL	Prescription	No	AB	203346	AUROBINDO PHARMA
ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET;ORAL	Prescription	No	AB	207507	CHARTWELL RX
ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET;ORAL	Prescription	No	AB	200739	NATCO
ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET;ORAL	Prescription	No	AB	074174	NOVITIUM PHARMA
ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET;ORAL	Prescription	No	AB	074112	SANDOZ
ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET;ORAL	Prescription	No	AB	090248	STRIDES PHARMA
ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET;ORAL	Prescription	No	AB	090082	SUN PHARM
XANAX	ALPRAZOLAM	0.25MG	TABLET;ORAL	Prescription	Yes	AB	018276	UPJOHN

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET;ORAL	Prescription	No	AB	074342	ACTAVIS ELIZABETH
ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET;ORAL	Prescription	No	AB	077741	APOTEX INC
ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET;ORAL	Prescription	No	AB	203346	AUROBINDO PHARMA
ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET;ORAL	Prescription	No	AB	207507	CHARTWELL RX
ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET;ORAL	Prescription	No	AB	200739	NATCO
ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET;ORAL	Prescription	No	AB	074174	NOVITIUM PHARMA
ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET;ORAL	Prescription	No	AB	074112	SANDOZ
ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET;ORAL	Prescription	No	AB	090248	STRIDES PHARMA
ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET;ORAL	Prescription	No	AB	090082	SUN PHARM
XANAX	ALPRAZOLAM	0.5MG	TABLET;ORAL	Prescription	Yes	AB	018276	UPJOHN

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET;ORAL	Prescription	No	AB	074342	ACTAVIS ELIZABETH
ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET;ORAL	Prescription	No	AB	077741	APOTEX INC
ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET;ORAL	Prescription	No	AB	203346	AUROBINDO PHARMA
ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET;ORAL	Prescription	No	AB	207507	CHARTWELL RX
ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET;ORAL	Prescription	No	AB	200739	NATCO
ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET;ORAL	Prescription	No	AB	074174	NOVITIUM PHARMA
ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET;ORAL	Prescription	No	AB	074112	SANDOZ
ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET;ORAL	Prescription	No	AB	090248	STRIDES PHARMA
ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET;ORAL	Prescription	No	AB	090082	SUN PHARM
XANAX	ALPRAZOLAM	1MG	TABLET;ORAL	Prescription	Yes	AB	018276	UPJOHN

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	077741	APOTEX INC
ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET;ORAL	Prescription	No	AB	203346	AUROBINDO PHARMA
ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET;ORAL	Prescription	No	AB	207507	CHARTWELL RX
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
ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET;ORAL	Prescription	No	AB	090248	STRIDES PHARMA
ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET;ORAL	Prescription	No	AB	090082	SUN PHARM
XANAX	ALPRAZOLAM	2MG	TABLET;ORAL	Prescription	Yes	AB	018276	UPJOHN

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