Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011556
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANTURANE SULFINPYRAZONE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
ANTURANE SULFINPYRAZONE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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
05/13/1959 ORIG-1 Approval Type 1 - New Molecular Entity 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
04/22/1999 SUPPL-54 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/26/2002 SUPPL-53 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/11556slr053ltr.pdf
09/12/1998 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/1993 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1992 SUPPL-50 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/13/1990 SUPPL-49 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/08/1987 SUPPL-48 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/02/1986 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

03/17/1987 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

04/07/1986 SUPPL-45 Labeling

Label is not available on this site.

12/08/1986 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

09/30/1985 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1985 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

10/08/1985 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1983 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/12/1984 SUPPL-38 Labeling

Label is not available on this site.

02/26/1980 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

10/27/1980 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1979 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

07/20/1979 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

07/20/1979 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/29/1978 SUPPL-32 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/26/1978 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

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