Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012302
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHOLOXIN DEXTROTHYROXINE SODIUM 2MG TABLET;ORAL Discontinued None No No
CHOLOXIN DEXTROTHYROXINE SODIUM 4MG TABLET;ORAL Discontinued None No No
CHOLOXIN DEXTROTHYROXINE SODIUM 1MG TABLET;ORAL Discontinued None No No
CHOLOXIN DEXTROTHYROXINE SODIUM 6MG 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
04/14/1967 ORIG-1 Approval Type 2 - New Active Ingredient 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
04/20/1989 SUPPL-45 Labeling

Label is not available on this site.

05/02/1984 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/1988 SUPPL-43 Labeling

Label is not available on this site.

04/13/1982 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

09/17/1980 SUPPL-39 Labeling

Label is not available on this site.

10/12/1978 SUPPL-32 Labeling

Label is not available on this site.

10/03/1975 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

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