Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074019
Company: AUROBINDO PHARMA USA

Products on ANDA 074019

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PINDOLOL	PINDOLOL	5MG	TABLET;ORAL	Prescription	AB	No	No
PINDOLOL	PINDOLOL	10MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074019

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/03/1992	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
08/12/2010	SUPPL-12	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
02/01/2000	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/02/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/02/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/05/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/18/1993	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074019

PINDOLOL

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PINDOLOL	PINDOLOL	5MG	TABLET;ORAL	Prescription	No	AB	073609	ANI PHARMS
PINDOLOL	PINDOLOL	5MG	TABLET;ORAL	Prescription	No	AB	074019	AUROBINDO PHARMA USA
PINDOLOL	PINDOLOL	5MG	TABLET;ORAL	Prescription	No	AB	211712	BAYSHORE PHARMS LLC
PINDOLOL	PINDOLOL	5MG	TABLET;ORAL	Prescription	No	AB	205415	NOSTRUM LABS INC
PINDOLOL	PINDOLOL	5MG	TABLET;ORAL	Prescription	No	AB	074063	SUN PHARM INDUSTRIES

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PINDOLOL	PINDOLOL	10MG	TABLET;ORAL	Prescription	No	AB	073609	ANI PHARMS
PINDOLOL	PINDOLOL	10MG	TABLET;ORAL	Prescription	No	AB	074019	AUROBINDO PHARMA USA
PINDOLOL	PINDOLOL	10MG	TABLET;ORAL	Prescription	No	AB	211712	BAYSHORE PHARMS LLC
PINDOLOL	PINDOLOL	10MG	TABLET;ORAL	Prescription	No	AB	205415	NOSTRUM LABS INC
PINDOLOL	PINDOLOL	10MG	TABLET;ORAL	Prescription	No	AB	074063	SUN PHARM INDUSTRIES