Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209942
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ALYQ | 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. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/28/2022 | SUPPL-5 | Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
ALYQ
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 | 210572 | CHARTWELL RX |
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 | 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 |