Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021368
Company: LILLY
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIALIS | TADALAFIL | 5MG | TABLET;ORAL | Prescription | AB1 | Yes | No |
| CIALIS | TADALAFIL | 10MG | TABLET;ORAL | Prescription | AB1 | Yes | No |
| CIALIS | TADALAFIL | 20MG | TABLET;ORAL | Prescription | AB1 | Yes | Yes |
| CIALIS | TADALAFIL | 2.5MG | TABLET;ORAL | Prescription | AB1 | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 11/21/2003 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Patient Package Insert (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021368lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21368ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021368ppilbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-368_Cialis.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/15/2018 | SUPPL-30 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021368s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021368Orig1s030ltr.pdf | |
| 05/05/2017 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021368s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021368Orig1s029ltr.pdf | |
| 07/12/2016 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/2016 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021368s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021368Orig1s027ltr.pdf | |
| 09/16/2015 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021368s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021368Orig1s026ltr.pdf | |
| 09/01/2015 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/2014 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021368s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021368Orig1s023ltr.pdf | |
| 10/10/2013 | SUPPL-22 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021368s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021368Orig1s022ltr.pdf | |
| 10/06/2011 | SUPPL-21 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021368s20s21lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021368s020,s021ltr.pdf | |
| 10/06/2011 | SUPPL-20 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021368s20s21lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021368s020,s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021368Orig1s020.pdf | |
| 02/01/2010 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021368s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021368s017ltr.pdf | |
| 08/07/2008 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021368s013ltr.pdf |
| 10/18/2007 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021368s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021368s012ltr.pdf | |
| 01/07/2008 | SUPPL-11 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021368s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021368s011ltr.pdf | |
| 10/23/2006 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s009,s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021368s009, s010ltr.pdf | |
| 10/23/2006 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s009,s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021368s009, s010ltr.pdf | |
| 03/07/2006 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021368s008ltr.pdf | |
| 01/22/2007 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021368s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021368s007ltr.pdf | |
| 07/08/2005 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021368s006ltr.pdf | |
| 03/31/2005 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s004,005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021368s004,005ltr.pdf | |
| 03/31/2005 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s004,005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021368s004,005ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/15/2018 | SUPPL-30 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021368s030lbl.pdf | |
| 05/05/2017 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021368s029lbl.pdf | |
| 04/22/2016 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021368s027lbl.pdf | |
| 09/16/2015 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021368s026lbl.pdf | |
| 04/29/2014 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021368s023lbl.pdf | |
| 10/10/2013 | SUPPL-22 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021368s022lbl.pdf | |
| 10/06/2011 | SUPPL-21 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021368s20s21lbl.pdf | |
| 10/06/2011 | SUPPL-20 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021368s20s21lbl.pdf | |
| 02/01/2010 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021368s017lbl.pdf | |
| 01/07/2008 | SUPPL-11 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021368s011lbl.pdf | |
| 10/18/2007 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021368s012lbl.pdf | |
| 01/22/2007 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021368s007lbl.pdf | |
| 10/23/2006 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s009,s010lbl.pdf | |
| 10/23/2006 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s009,s010lbl.pdf | |
| 03/07/2006 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s008lbl.pdf | |
| 07/08/2005 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s006lbl.pdf | |
| 03/31/2005 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s004,005lbl.pdf | |
| 03/31/2005 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s004,005lbl.pdf | |
| 11/21/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021368lbl.pdf |
CIALIS
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 |
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 |