Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016322
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VALISONE BETAMETHASONE VALERATE EQ 0.1% BASE CREAM;TOPICAL Discontinued None No No
VALISONE BETAMETHASONE VALERATE EQ 0.01% BASE CREAM;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
09/02/1967 ORIG-1 Approval Type 2 - New Active Ingredient 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
11/08/1991 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

10/29/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/12/1986 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/20/1986 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1986 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/31/1984 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/05/1983 SUPPL-15 Labeling

Label is not available on this site.

04/16/1982 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/15/1981 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/13/1982 SUPPL-12 Labeling

Label is not available on this site.

08/13/1981 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/26/1979 SUPPL-10 Labeling

Label is not available on this site.

05/31/1979 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1980 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1980 SUPPL-7 Labeling

Label is not available on this site.

09/26/1977 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

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