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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077342
Company: TEVA

Products on ANDA 077342

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	AB	No	No
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	AB	No	No
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077342

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/2016	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/077342Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 077342

SILDENAFIL CITRATE

TABLET;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	206401	AJANTA PHARMA LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	202023	AMNEAL PHARMS NY
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	207178	APPCO
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	203962	AUROBINDO PHARMA LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	218045	CADILA PHARMS LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	212051	CHARTWELL RX
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	202659	HETERO LABS LTD V
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	202255	MACLEODS PHARMS LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	201171	MYLAN
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	216383	NOVITIUM PHARMA
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	208494	REYOUNG
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	204882	RUBICON
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	213032	SUNSHINE
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	077342	TEVA
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	091448	TORRENT
VIAGRA	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET;ORAL	Prescription	Yes	AB	020895	VIATRIS

TABLET;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	206401	AJANTA PHARMA LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	202023	AMNEAL PHARMS NY
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	207178	APPCO
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	203962	AUROBINDO PHARMA LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	218045	CADILA PHARMS LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	212051	CHARTWELL RX
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	202659	HETERO LABS LTD V
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	202255	MACLEODS PHARMS LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	201171	MYLAN
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	216383	NOVITIUM PHARMA
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	208494	REYOUNG
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	204882	RUBICON
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	213032	SUNSHINE
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	077342	TEVA
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	091448	TORRENT
VIAGRA	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET;ORAL	Prescription	Yes	AB	020895	VIATRIS

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	206401	AJANTA PHARMA LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	202023	AMNEAL PHARMS NY
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	207178	APPCO
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	203962	AUROBINDO PHARMA LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	218045	CADILA PHARMS LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	212051	CHARTWELL RX
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	202659	HETERO LABS LTD V
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	202255	MACLEODS PHARMS LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	201171	MYLAN
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	216383	NOVITIUM PHARMA
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	208494	REYOUNG
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	204882	RUBICON
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	213032	SUNSHINE
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	077342	TEVA
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	091448	TORRENT
VIAGRA	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET;ORAL	Prescription	Yes	AB	020895	VIATRIS

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