Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012383
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COLBENEMID COLCHICINE; PROBENECID 0.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
07/27/1961 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
08/18/1994 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1994 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1989 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

05/12/1988 SUPPL-24 Labeling

Label is not available on this site.

05/12/1988 SUPPL-23 Labeling

Label is not available on this site.

05/12/1988 SUPPL-21 Labeling

Label is not available on this site.

03/02/1982 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/23/1985 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/24/1979 SUPPL-16 Labeling

Label is not available on this site.

05/10/1979 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/21/1981 SUPPL-14 Labeling

Label is not available on this site.

06/01/1978 SUPPL-13 Labeling

Label is not available on this site.

05/30/1979 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

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