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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202023
Company: AMNEAL PHARMS NY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription AB No No
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription AB No No
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/27/2018 ORIG-1 Approval Not Applicable

Label is not available on this site.

SILDENAFIL CITRATE

TABLET;ORAL; EQ 25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription No AB 206401 AJANTA PHARMA LTD
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription No AB 202023 AMNEAL PHARMS NY
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription No AB 207178 APPCO
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription No AB 203962 AUROBINDO PHARMA LTD
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription No AB 202659 HETERO LABS LTD V
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription No AB 212051 LUPIN LTD
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription No AB 201171 MYLAN
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription No AB 208494 REYOUNG
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription No AB 204882 RUBICON
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription No AB 213032 SUNSHINE
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription No AB 077342 TEVA
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription No AB 091448 TORRENT
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription No AB 209302 UMEDICA LABS PVT LTD
VIAGRA SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription Yes AB 020895 VIATRIS

TABLET;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription No AB 206401 AJANTA PHARMA LTD
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription No AB 202023 AMNEAL PHARMS NY
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription No AB 207178 APPCO
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription No AB 203962 AUROBINDO PHARMA LTD
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription No AB 202659 HETERO LABS LTD V
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription No AB 212051 LUPIN LTD
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription No AB 201171 MYLAN
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription No AB 208494 REYOUNG
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription No AB 204882 RUBICON
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription No AB 213032 SUNSHINE
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription No AB 077342 TEVA
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription No AB 091448 TORRENT
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription No AB 209302 UMEDICA LABS PVT LTD
VIAGRA SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription Yes AB 020895 VIATRIS

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription No AB 206401 AJANTA PHARMA LTD
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription No AB 202023 AMNEAL PHARMS NY
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription No AB 207178 APPCO
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription No AB 203962 AUROBINDO PHARMA LTD
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription No AB 202659 HETERO LABS LTD V
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription No AB 212051 LUPIN LTD
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription No AB 201171 MYLAN
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription No AB 208494 REYOUNG
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription No AB 204882 RUBICON
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription No AB 213032 SUNSHINE
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription No AB 077342 TEVA
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription No AB 091448 TORRENT
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription No AB 209302 UMEDICA LABS PVT LTD
VIAGRA SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription Yes AB 020895 VIATRIS
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