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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209907
Company: HETERO LABS LTD III
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription AB2 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
02/05/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

TADALAFIL

TABLET;ORAL; 20MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADCIRCA TADALAFIL 20MG TABLET;ORAL Prescription Yes AB2 022332 ELI LILLY CO
ALYQ TADALAFIL 20MG TABLET;ORAL Prescription No AB2 216932 TEVA PHARMS INC
ALYQ TADALAFIL 20MG TABLET;ORAL Prescription No AB2 209942 TEVA PHARMS USA
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB2 210392 AJANTA PHARMA LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB2 206286 AUROBINDO PHARMA LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB2 210255 CIPLA
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB2 210145 DR REDDYS
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB2 209907 HETERO LABS LTD III
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB2 210572 LUPIN LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB2 207290 MACLEODS PHARMS LTD
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB2 210608 PRINSTON INC
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB2 213496 SUNSHINE
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB2 212062 TORRENT
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