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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019649
Company: SUN PHARM INDS INC

Products on NDA 019649

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUMADINE	RIMANTADINE HYDROCHLORIDE	100MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019649

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.

Labels for NDA 019649

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

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