Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211335
Company: SUNSHINE
Company: SUNSHINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | AB1 | No | No |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | AB1 | No | No |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | AB1 | No | No |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | AB1 | 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 |
|---|---|---|---|---|---|---|---|
| 03/26/2019 | 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 |
|---|---|---|---|---|---|
| 01/07/2021 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
TADALAFIL
TABLET;ORAL; 2.5MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIALIS | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | Yes | AB1 | 021368 | LILLY |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 209167 | ACCORD HLTHCARE |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 209654 | AJANTA PHARMA LTD |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 204809 | ALEMBIC |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 209744 | AMNEAL PHARMS CO |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 206285 | AUROBINDO PHARMA LTD |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 209539 | CIPLA |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 210069 | DR REDDYS |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 208824 | HANGZHOU BINJIANG |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 209908 | HETERO LABS LTD III |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 210567 | LUPIN LTD |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 207244 | MACLEODS PHARMS LTD |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 210609 | PRINSTON INC |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 210420 | QILU PHARM HAINAN |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 208934 | SUN PHARM |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 211335 | SUNSHINE |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 090141 | TEVA PHARMS USA |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 211839 | TORRENT |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 211298 | UMEDICA |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 209250 | UNICHEM |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 215556 | VKT PHARMA |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 205885 | WATSON LABS INC |
| TADALAFIL | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 206693 | ZYDUS PHARMS |
TABLET;ORAL; 5MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIALIS | TADALAFIL | 5MG | TABLET;ORAL | Prescription | Yes | AB1 | 021368 | LILLY |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 209167 | ACCORD HLTHCARE |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 209654 | AJANTA PHARMA LTD |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 204809 | ALEMBIC |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 209744 | AMNEAL PHARMS CO |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 206285 | AUROBINDO PHARMA LTD |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 209539 | CIPLA |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 210069 | DR REDDYS |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 208824 | HANGZHOU BINJIANG |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 209908 | HETERO LABS LTD III |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 210567 | LUPIN LTD |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 207244 | MACLEODS PHARMS LTD |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 215949 | NOVITIUM PHARMA |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 210609 | PRINSTON INC |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 210420 | QILU PHARM HAINAN |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 208934 | SUN PHARM |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 211335 | SUNSHINE |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 090141 | TEVA PHARMS USA |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 211839 | TORRENT |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 211298 | UMEDICA |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 209250 | UNICHEM |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 215556 | VKT PHARMA |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 205885 | WATSON LABS INC |
| TADALAFIL | TADALAFIL | 5MG | TABLET;ORAL | Prescription | No | AB1 | 206693 | ZYDUS PHARMS |
TABLET;ORAL; 10MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIALIS | TADALAFIL | 10MG | TABLET;ORAL | Prescription | Yes | AB1 | 021368 | LILLY |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 209167 | ACCORD HLTHCARE |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 209654 | AJANTA PHARMA LTD |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 204809 | ALEMBIC |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 209744 | AMNEAL PHARMS CO |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 206285 | AUROBINDO PHARMA LTD |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 209539 | CIPLA |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 210069 | DR REDDYS |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 208824 | HANGZHOU BINJIANG |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 209908 | HETERO LABS LTD III |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 210567 | LUPIN LTD |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 207244 | MACLEODS PHARMS LTD |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 215949 | NOVITIUM PHARMA |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 210609 | PRINSTON INC |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 210420 | QILU PHARM HAINAN |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 208934 | SUN PHARM |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 211335 | SUNSHINE |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 090141 | TEVA PHARMS USA |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 211839 | TORRENT |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 211298 | UMEDICA |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 209250 | UNICHEM |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 215556 | VKT PHARMA |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 205885 | WATSON LABS INC |
| TADALAFIL | TADALAFIL | 10MG | TABLET;ORAL | Prescription | No | AB1 | 206693 | ZYDUS PHARMS |
TABLET;ORAL; 20MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIALIS | TADALAFIL | 20MG | TABLET;ORAL | Prescription | Yes | AB1 | 021368 | LILLY |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 209167 | ACCORD HLTHCARE |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 209654 | AJANTA PHARMA LTD |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 204809 | ALEMBIC |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 209744 | AMNEAL PHARMS CO |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 206285 | AUROBINDO PHARMA LTD |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 209539 | CIPLA |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 210069 | DR REDDYS |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 208824 | HANGZHOU BINJIANG |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 209908 | HETERO LABS LTD III |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 210567 | LUPIN LTD |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 207244 | MACLEODS PHARMS LTD |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 215949 | NOVITIUM PHARMA |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 210609 | PRINSTON INC |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 210420 | QILU PHARM HAINAN |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 216279 | SHANDONG |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 208934 | SUN PHARM |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 211335 | SUNSHINE |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 090141 | TEVA PHARMS USA |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 211839 | TORRENT |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 211298 | UMEDICA |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 209250 | UNICHEM |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 215556 | VKT PHARMA |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 205885 | WATSON LABS INC |
| TADALAFIL | TADALAFIL | 20MG | TABLET;ORAL | Prescription | No | AB1 | 206693 | ZYDUS PHARMS |