ADCIRCA از شرکت ELI LILLY CO

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

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022332lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022332s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022332_adcirca_toc.cfm

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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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