Orange Book product · Brand (NDA)
REVATIO
SILDENAFIL CITRATE
At a glance
Nov 18, 2009
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 18, 2009
16 yr 10 mo ago
Exclusivity ends · M-287
New use / labeling-change exclusivity (3 years)
Jan 31, 2026
5 mo ago
Today
Pharmaceutical detail
Active ingredient
SILDENAFIL CITRATE
Strength
EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 022473
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025VYBRIQUEBrand (NDA)
NDA 210858 · IBSA
- 2023LIQREVBrand (NDA)
NDA 214952 · CMP DEV LLC
- 2012REVATIOBrand (NDA)
NDA 203109 · VIATRIS
- 2005REVATIOBrand (NDA)
NDA 021845 · VIATRIS
- 2025SILDENAFIL CITRATEGeneric (ANDA)
ANDA 202954 · JUBILANT GENERICS
- 2024SILDENAFIL CITRATEGeneric (ANDA)
ANDA 201156 · JUBILANT GENERICS
- 2023SILDENAFIL CITRATEGeneric (ANDA)
ANDA 214556 · GRANULES
- 2023SILDENAFIL CITRATEGeneric (ANDA)
ANDA 218045 · CADILA PHARMS LTD
- 2023SILDENAFIL CITRATEGeneric (ANDA)
ANDA 216383 · NOVITIUM PHARMA
- 2023SILDENAFIL CITRATEGeneric (ANDA)
ANDA 202255 · MACLEODS PHARMS LTD
- 2022SILDENAFIL CITRATEGeneric (ANDA)
ANDA 214773 · AUROBINDO PHARMA LTD
- 2022SILDENAFIL CITRATEGeneric (ANDA)
ANDA 215708 · ZYDUS LIFESCIENCES
Marketing exclusivity (1)
- M-287New use / labeling-change exclusivity (3 years)
Jan 31, 2026
5 mo ago
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
