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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203346
Company: AUROBINDO PHARMA

Products on ANDA 203346

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 203346

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2015	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
08/29/2023	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/29/2023	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/29/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/31/2019	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203346

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	BRECKENRIDGE
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	BRECKENRIDGE
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	BRECKENRIDGE
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	BRECKENRIDGE
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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