Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207290
Company: MACLEODS PHARMS LTD
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 | 213496 | SUNSHINE |
TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB2 | 212062 | TORRENT |
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