Orange Book product · Generic (ANDA)
SILDENAFIL CITRATE
SILDENAFIL CITRATE
At a glance
May 11, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 11, 2021
5 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
SILDENAFIL CITRATE
Strength
EQ 10MG BASE/ML
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
AB
Application
ANDA 213014
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
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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
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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.
