Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207290
Company: MACLEODS PHARMS LTD

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
10/16/2019 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 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 LABS LTD
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 200630 MYLAN
TADALAFIL TADALAFIL 20MG TABLET;ORAL Prescription No AB2 212062 TORRENT

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