Drugs@FDA: FDA Approved Drug Products

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

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