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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078380
Company: TEVA PHARMS

Products on ANDA 078380

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078380

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/07/2013	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/78380TA_ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/2020	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/25/2020	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/25/2020	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/10/2015	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/02/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078380

SILDENAFIL CITRATE

TABLET;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
REVATIO	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	Yes	AB	021845	VIATRIS
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	210394	AJANTA PHARMA LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	202025	AMNEAL PHARMS
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	203963	AUROBINDO PHARMA LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	202598	CHARTWELL RX
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	203623	HETERO LABS LTD V
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	203814	MACLEODS PHARMS LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	204883	RUBICON
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	078380	TEVA PHARMS
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	091479	TORRENT PHARMS LTD
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	202503	WATSON LABS INC

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