اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ADCIRCA از شرکت ELI LILLY CO
New Drug Application (NDA): 022332
Company: ELI LILLY CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADCIRCA | TADALAFIL | 20MG | TABLET;ORAL | Prescription |
AB2 |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/22/2009 | ORIG-1 | Approval |
Type 6 – New Indication (no longer used) |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022332lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/15/2020 | SUPPL-11 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022332Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022332Orig1s011ltr.pdf |
||
| 05/05/2017 | SUPPL-9 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022332s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022332Orig1s009ltr.pdf |
||
| 04/02/2015 | SUPPL-7 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022332s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022332Orig1s007ltr.pdf |
||
| 04/29/2014 | SUPPL-6 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022332s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022332Orig1s006ltr.pdf |
||
| 11/20/2013 | SUPPL-5 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022332s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022332Orig1s005ltr.pdf |
||
| 02/08/2011 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022332s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022332s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/15/2020 | SUPPL-11 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022332Orig1s011lbl.pdf | |
| 05/05/2017 | SUPPL-9 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022332s009lbl.pdf | |
| 04/02/2015 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022332s007lbl.pdf | |
| 04/29/2014 | SUPPL-6 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022332s006lbl.pdf | |
| 11/20/2013 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022332s005lbl.pdf | |
| 02/08/2011 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022332s003lbl.pdf | |
| 05/22/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022332lbl.pdf |
ADCIRCA
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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