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New Drug Application (NDA): 019649
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUMADINE RIMANTADINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription AB 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
09/17/1993 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/19/2015 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/05/2010 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019649s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019649s015ltr.pdf
11/21/2008 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019649s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019649s014ltr.pdf
12/18/2008 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/2008 SUPPL-12 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-10 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-6 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-4 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-1 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
04/05/2010 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019649s015lbl.pdf
11/21/2008 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019649s014lbl.pdf
03/14/2007 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019649s010,019650s007lbl.pdf
04/06/2001 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19650S4lbl.pdf

FLUMADINE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUMADINE RIMANTADINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription Yes AB 019649 SUN PHARM INDS INC
RIMANTADINE HYDROCHLORIDE RIMANTADINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 076132 IMPAX LABS
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