Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018689
Company: SEBELA IRELAND LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIDAURA AURANOFIN 3MG CAPSULE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/24/1985 ORIG-1 Approval Type 1 - New Molecular Entity 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
05/14/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/23/2002 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/22/1999 SUPPL-15 Labeling

Label is not available on this site.

12/22/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/02/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/23/1998 SUPPL-12 Labeling

Label is not available on this site.

04/23/1998 SUPPL-11 Labeling

Label is not available on this site.

04/13/1989 SUPPL-10 Labeling

Label is not available on this site.

11/02/1987 SUPPL-8 Labeling

Label is not available on this site.

11/02/1987 SUPPL-7 Labeling

Label is not available on this site.

04/27/1987 SUPPL-6 Labeling

Label is not available on this site.

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