Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209321
Company: JACOBUS PHARM CO INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RUZURGI AMIFAMPRIDINE 10MG TABLET;ORAL 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
05/06/2019 ORIG-2 Tentative Approval Efficacy PRIORITY; Orphan Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209321Orig2s000_TAltr.pdf
05/06/2019 ORIG-1 Approval Type 2 - New Active Ingredient PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209321s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209321Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209321Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/21/2020 SUPPL-1 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209321Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/06/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209321s000lbl.pdf

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