Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 022505
Company: THERATECHNOLOGIES
Company: THERATECHNOLOGIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EGRIFTA | TESAMORELIN ACETATE | EQ 1MG BASE/VIAL | POWDER;SUBCUTANEOUS | Prescription | None | No | No |
EGRIFTA | TESAMORELIN ACETATE | EQ 2MG BASE/VIAL | POWDER;SUBCUTANEOUS | Prescription | None | No | No |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/27/2024 | SUPPL-18 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022505s018lbl.pdf | |
02/27/2024 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022505s018lbl.pdf | |
02/27/2024 | SUPPL-18 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022505s018lbl.pdf | |
07/05/2019 | SUPPL-13 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf | |
07/05/2019 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf | |
07/05/2019 | SUPPL-13 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf | |
07/05/2019 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf | |
07/05/2019 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf | |
07/05/2019 | SUPPL-12 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf | |
07/05/2019 | SUPPL-12 | Labeling-Proprietary Name Change | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s012s013lbl.pdf | |
01/18/2019 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505s011lbl.pdf | |
06/08/2015 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022505s007lbl.pdf | |
01/07/2013 | SUPPL-4 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022505s004lbl.pdf | |
11/29/2011 | SUPPL-3 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022505s001s003lbl.pdf | |
11/29/2011 | SUPPL-1 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022505s001s003lbl.pdf |
11/10/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022505s000lbl.pdf | |
SUPPL-10 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022505Orig1s010lbl.pdf |