Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203988
Company: EUGIA PHARMA

Products on ANDA 203988

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203988

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/01/2015	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/22/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/19/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203988

SILDENAFIL CITRATE

SOLUTION;INTRAVENOUS; EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
REVATIO	SILDENAFIL CITRATE	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	022473	VIATRIS
SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	203988	EUGIA PHARMA