Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018148
Company: IVAX RES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NASALIDE FLUNISOLIDE 0.025MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SPRAY, METERED;NASAL Discontinued None No No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
09/24/1981 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
08/23/2002 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/2002 SUPPL-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18148S030ltr.pdf
09/13/2000 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/29/2000 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/09/2002 SUPPL-30 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-29 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1998 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/07/2007 SUPPL-26 Labeling

Label is not available on this site.

08/05/1994 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1994 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1999 SUPPL-23 Efficacy-New Dosing Regimen Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18148s023_nasalide.pdf
03/07/1989 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/08/1989 SUPPL-21 Labeling

Label is not available on this site.

12/23/1987 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-18 Labeling

Label is not available on this site.

12/07/2007 SUPPL-16 Labeling

Label is not available on this site.

09/19/1986 SUPPL-15 Labeling

Label is not available on this site.

08/25/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/11/1985 SUPPL-13 Labeling

Label is not available on this site.

09/23/1985 SUPPL-12 Labeling

Label is not available on this site.

08/19/1986 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1984 SUPPL-10 Labeling

Label is not available on this site.

02/21/1985 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1986 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/22/1983 SUPPL-6 Labeling

Label is not available on this site.

09/09/1983 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/09/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/09/1983 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/09/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/30/1983 SUPPL-1 Labeling

Label is not available on this site.

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