Orange Book product · Generic (ANDA)
SILDENAFIL CITRATE
SILDENAFIL CITRATE
At a glance
Jun 12, 2020
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 12, 2020
6 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
SILDENAFIL CITRATE
Strength
EQ 25MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 208494
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of SILDENAFIL CITRATE
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- 2009REVATIOBrand (NDA)
NDA 022473 · VIATRIS
- 2005REVATIOBrand (NDA)
NDA 021845 · VIATRIS
- 2025SILDENAFIL CITRATEGeneric (ANDA)
ANDA 202954 · JUBILANT GENERICS
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ANDA 201156 · JUBILANT GENERICS
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ANDA 214556 · GRANULES
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ANDA 218045 · CADILA PHARMS LTD
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ANDA 216383 · NOVITIUM PHARMA
- 2023SILDENAFIL CITRATEGeneric (ANDA)
ANDA 202255 · MACLEODS PHARMS LTD
- 2022SILDENAFIL CITRATEGeneric (ANDA)
ANDA 214773 · AUROBINDO PHARMA LTD
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.
