Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020409
Company: TEVA BRANDED PHARM

Products on NDA 020409

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NASAREL	FLUNISOLIDE	0.029MG/SPRAY	SPRAY, METERED;NASAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020409

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/08/1995	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/17/2008	SUPPL-22	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020409s022ltr.pdf
08/23/2002	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
05/09/2002	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18148S030ltr.pdf
06/29/2000	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/15/2000	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/27/2001	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20409S6LTR.PDF
05/09/2002	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18148S030ltr.pdf
02/05/1999	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
04/21/1998	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
10/01/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.