Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018312
Company: ORGANON USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALDEROL CALCIFEDIOL 0.02MG CAPSULE;ORAL Discontinued None No No
CALDEROL CALCIFEDIOL 0.05MG CAPSULE;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
08/05/1980 ORIG-1 Approval Type 1 - New Molecular Entity 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
06/15/2000 SUPPL-12 Labeling

Label is not available on this site.

12/09/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/18/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/30/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/16/1986 SUPPL-8 Labeling

Label is not available on this site.

06/16/1986 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1984 SUPPL-4 Labeling

Label is not available on this site.

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