Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021264
Company: MDD US
Company: MDD US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
APOKYN | APOMORPHINE HYDROCHLORIDE | 20MG/2ML (10MG/ML) | INJECTABLE;SUBCUTANEOUS | Discontinued | None | No | No |
APOKYN | APOMORPHINE HYDROCHLORIDE | 30MG/3ML (10MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | AP | Yes | Yes |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/03/2025 | SUPPL-25 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021264s025lbl.pdf | |
06/22/2022 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021264s021lbl.pdf | |
06/22/2022 | SUPPL-21 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021264s021lbl.pdf | |
05/05/2022 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021264s022lbl.pdf | |
05/05/2022 | SUPPL-22 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021264s022lbl.pdf | |
05/01/2020 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021264s018lbl.pdf | |
12/03/2019 | SUPPL-17 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021264Orig1s017lbl.pdf | |
12/03/2019 | SUPPL-17 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021264Orig1s017lbl.pdf | |
12/03/2019 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021264Orig1s017lbl.pdf | |
05/20/2019 | SUPPL-16 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021264s016lbl.pdf | |
05/20/2019 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021264s016lbl.pdf | |
03/16/2017 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021264s014lbl.pdf | |
07/25/2014 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021264s010lbl.pdf | |
09/02/2010 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021264s009lbl.pdf | |
04/20/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21264_apokyn_lbl.pdf |