Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211712
Company: BAYSHORE PHARMS LLC

Products on ANDA 211712

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211712

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/01/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211712

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