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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021264
Company: MDD US

Products on NDA 021264

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021264

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-Package Insert, Labeling-Patient 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-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert	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-Package Insert, Labeling-Patient 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

Labels for NDA 021264

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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-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
05/20/2019	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021264s016lbl.pdf
05/20/2019	SUPPL-16	Labeling-Patient 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

Therapeutic Equivalents for NDA 021264

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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