U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021318
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
Back to Top