Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011323
Company: SHIRE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FUROXONE FURAZOLIDONE 50MG/15ML SUSPENSION;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
01/20/1958 ORIG-1 Approval Type 4 - New Combination 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
04/15/1999 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1999 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1996 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/03/1987 SUPPL-15 Labeling

Label is not available on this site.

06/20/1986 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/20/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

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