Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012542
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TANDEARIL OXYPHENBUTAZONE 100MG TABLET;ORAL 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
12/21/1960 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
03/25/1985 SUPPL-56 Labeling

Label is not available on this site.

08/13/1984 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1983 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

09/14/1982 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

07/25/1980 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

09/06/1979 SUPPL-49 Labeling

Label is not available on this site.

08/08/1979 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

09/03/1982 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/1978 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

12/16/1977 SUPPL-45 Labeling

Label is not available on this site.

12/16/1977 SUPPL-44 Labeling

Label is not available on this site.

04/26/1979 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/28/1978 SUPPL-42 Labeling

Label is not available on this site.

02/09/1979 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1979 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1977 SUPPL-39 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/05/1978 SUPPL-37 Labeling

Label is not available on this site.

04/29/1977 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

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