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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209745
Company: AMNEAL PHARMS CO

Products on ANDA 209745

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	AB	No	No
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209745

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209745

SILODOSIN

CAPSULE;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RAPAFLO	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	Yes	AB	022206	ALLERGAN
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	211060	AJANTA PHARMA LTD
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	209745	AMNEAL PHARMS CO
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	210626	AUROBINDO PHARMA LTD
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	204726	CHARTWELL RX
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	213230	CREEKWOOD PHARMS
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	204793	HETERO LABS LTD V
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	206541	LUPIN LTD
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	211166	MACLEODS PHARMS LTD
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	210687	MSN
SILODOSIN	SILODOSIN	4MG	CAPSULE;ORAL	Prescription	No	AB	209029	PRINSTON INC

CAPSULE;ORAL; 8MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RAPAFLO	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	Yes	AB	022206	ALLERGAN
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	211060	AJANTA PHARMA LTD
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	209745	AMNEAL PHARMS CO
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	210626	AUROBINDO PHARMA LTD
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	204726	CHARTWELL RX
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	213230	CREEKWOOD PHARMS
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	204793	HETERO LABS LTD V
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	206541	LUPIN LTD
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	211166	MACLEODS PHARMS LTD
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	210687	MSN
SILODOSIN	SILODOSIN	8MG	CAPSULE;ORAL	Prescription	No	AB	209029	PRINSTON INC

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