An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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-Patient Package Insert, Labeling-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

Top