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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213014
Company: HETERO LABS LTD V

Products on ANDA 213014

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213014

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213014

SILDENAFIL CITRATE

FOR SUSPENSION;ORAL; EQ 10MG BASE/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
REVATIO	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	Yes	AB	203109	VIATRIS
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	212883	AJANTA PHARMA LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	212440	ALKEM LABS LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	211092	AMNEAL PHARMS
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	213814	APPCO
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	213041	APTAPHARMA INC
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	214773	AUROBINDO PHARMA LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	214556	GRANULES
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	213014	HETERO LABS LTD V
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	211638	LUPIN LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	214641	MSN
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	212260	NOVITIUM PHARMA
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	215522	TARO
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	211534	TEVA PHARMS USA
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION;ORAL	Prescription	No	AB	215708	ZYDUS LIFESCIENCES

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