Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012657
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CELESTONE BETAMETHASONE 0.6MG TABLET;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
04/17/1961 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
11/19/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/16/1998 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/10/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/13/1994 SUPPL-20 Labeling

Label is not available on this site.

08/10/1994 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1993 SUPPL-18 Labeling

Label is not available on this site.

12/17/1992 SUPPL-17 Labeling

Label is not available on this site.

04/02/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/20/1986 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/23/1982 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/26/1983 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/11/1981 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/23/1979 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/1979 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/08/1978 SUPPL-5 Labeling

Label is not available on this site.

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