Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019650
Company: FOREST LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUMADINE RIMANTADINE HYDROCHLORIDE 50MG/5ML SYRUP;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/17/1993 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19650S4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19650S4ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/08/2008 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019649s012,019650s009ltr.pdf
03/14/2007 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019649s010,019650s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019649s010;019650s007ltr.pdf
04/06/2001 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19650S4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19650S4ltr.pdf
11/08/1999 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/14/2007 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019649s010,019650s007lbl.pdf
04/06/2001 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19650S4lbl.pdf
09/17/1993 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19650S4lbl.pdf

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