Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021318
Company: LILLY
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FORTEO | TERIPARATIDE | 0.75MG/3ML (0.25MG/ML) | SOLUTION;SUBCUTANEOUS | Discontinued | None | No | No |
| FORTEO | TERIPARATIDE | 0.6MG/2.4ML (0.25MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 11/26/2002 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21318_forteo_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21318.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-318_Forteo.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/07/2021 | SUPPL-56 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021318Orig1s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021318Orig1s056ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/021318Orig1s056.pdf | |
| 11/16/2020 | SUPPL-54 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021318Orig1s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021318Orig1s054ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021318Orig1s054.pdf | |
| 04/06/2020 | SUPPL-53 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021318s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021318Orig1s053ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/021318Orig1s053.pdf | |
| 10/03/2019 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021318s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021318Orig1s052ltr.pdf | |
| 04/28/2017 | SUPPL-51 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021318Orig1s051ltr.pdf |
| 11/23/2015 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/2014 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/2014 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/2014 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/2014 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/2014 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/2013 | SUPPL-36 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021318s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021318Orig1s036ltr.pdf | |
| 08/02/2013 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/2013 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/2013 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/2012 | SUPPL-27 | Labeling-Medication Guide |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021318s027ltr.pdf |
| 08/10/2011 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021318s026ltr.pdf |
| 06/25/2008 | SUPPL-16 | Labeling-Package Insert |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021318s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021318Orig1s016.pdf |
| 02/28/2008 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021318s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021318s015ltr.pdf | |
| 07/22/2009 | SUPPL-12 | Efficacy-New Indication, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021318s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021318s012ltr.pdf | |
| 05/19/2007 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021318s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021318s009ltr.pdf | |
| 09/03/2004 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21318s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21318s004ltr.pdf | |
| 06/02/2004 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21318slr002_forteo_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21318slr002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/07/2021 | SUPPL-56 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021318Orig1s056lbl.pdf | |
| 09/07/2021 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021318Orig1s056lbl.pdf | |
| 11/16/2020 | SUPPL-54 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021318Orig1s054lbl.pdf | |
| 04/06/2020 | SUPPL-53 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021318s053lbl.pdf | |
| 04/06/2020 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021318s053lbl.pdf | |
| 10/03/2019 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021318s052lbl.pdf | |
| 08/30/2013 | SUPPL-36 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021318s036lbl.pdf | |
| 07/22/2009 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021318s012lbl.pdf | |
| 07/22/2009 | SUPPL-12 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021318s012lbl.pdf | |
| 02/28/2008 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021318s015lbl.pdf | |
| 05/19/2007 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021318s009lbl.pdf | |
| 09/03/2004 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21318s004lbl.pdf | |
| 06/02/2004 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21318slr002_forteo_lbl.pdf | |
| 11/26/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21318_forteo_lbl.pdf |
FORTEO
SOLUTION;SUBCUTANEOUS; 0.6MG/2.4ML (0.25MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FORTEO | TERIPARATIDE | 0.6MG/2.4ML (0.25MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | Yes | AP | 021318 | LILLY |
| TERIPARATIDE | TERIPARATIDE | 0.6MG/2.4ML (0.25MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 211097 | APOTEX |
| TERIPARATIDE | TERIPARATIDE | 0.6MG/2.4ML (0.25MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 208569 | TEVA PHARMS USA |