Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021264
Company: US WORLDMEDS
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 None 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
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
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English