Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 005795
Company: SHIRE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FURACIN NITROFURAZONE 0.2% OINTMENT;TOPICAL 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
10/04/1945 ORIG-1 Approval Type 3 - New Dosage Form 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
02/09/2000 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/21/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/21/1998 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/09/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/26/1982 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/12/1984 SUPPL-7 Labeling

Label is not available on this site.

02/17/1982 SUPPL-6 Labeling

Label is not available on this site.

09/12/1980 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/11/1979 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/12/1978 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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