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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021264
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/20/2004 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21264_apokyn_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21264ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-264_Apokyn.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/05/2022 SUPPL-22 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021264s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021264Orig1s022ltr.pdf
06/22/2022 SUPPL-21 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021264s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021264Orig1s021ltr.pdf
05/01/2020 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021264s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021264Orig1s018ltr.pdf
12/03/2019 SUPPL-17 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021264Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021264Orig1s017ltr.pdf
05/20/2019 SUPPL-16 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021264s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021264Orig1s016ltr.pdf
03/16/2017 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021264s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021264Orig1s014ltr.pdf
07/25/2014 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021264s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021264Orig1s010ltr.pdf
09/02/2010 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021264s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021264s009ltr.pdf
12/31/2008 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021264s003,021264s005ltr.pdf
12/31/2008 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021264s003,021264s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/22/2022 SUPPL-21 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021264s021lbl.pdf
06/22/2022 SUPPL-21 Labeling-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-Package Insert 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-Container/Carton Labels 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

APOKYN

INJECTABLE;SUBCUTANEOUS; 30MG/3ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APOKYN APOMORPHINE HYDROCHLORIDE 30MG/3ML (10MG/ML) INJECTABLE;SUBCUTANEOUS Prescription Yes AP 021264 MDD US
APOMORPHINE HYDROCHLORIDE APOMORPHINE HYDROCHLORIDE 30MG/3ML (10MG/ML) INJECTABLE;SUBCUTANEOUS Prescription No AP 212025 SAGE CHEMS
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