Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077342
Company: TEVA
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
03/09/2016 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/077342Orig1s000ltr.pdf

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 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 204882 RUBICON
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
VIAGRA SILDENAFIL CITRATE EQ 25MG BASE TABLET;ORAL Prescription Yes AB 020895 PFIZER INC

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 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 204882 RUBICON
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
VIAGRA SILDENAFIL CITRATE EQ 50MG BASE TABLET;ORAL Prescription Yes AB 020895 PFIZER INC

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 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 204882 RUBICON
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
VIAGRA SILDENAFIL CITRATE EQ 100MG BASE TABLET;ORAL Prescription Yes AB 020895 PFIZER INC

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