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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019650
Company: FOREST LABS

Products on NDA 019650

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019650

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.

Labels for NDA 019650

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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