Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016740
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VALISONE BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT;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
02/17/1969 ORIG-1 Approval Type 3 - New Dosage Form 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-18 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1986 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/20/1986 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1986 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1986 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/16/1982 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/15/1981 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/15/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1982 SUPPL-10 Labeling

Label is not available on this site.

12/26/1979 SUPPL-9 Labeling

Label is not available on this site.

05/31/1979 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1980 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1980 SUPPL-6 Labeling

Label is not available on this site.

09/06/1977 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/31/1974 SUPPL-4

Label is not available on this site.

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