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 | None | Yes | Yes |
| 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 |