Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018861
Company: FOUGERA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BETAMETHASONE VALERATE BETAMETHASONE VALERATE EQ 0.1% BASE CREAM;TOPICAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/31/1983 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/04/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/12/1996 SUPPL-8 Labeling

Label is not available on this site.

03/07/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/14/1988 SUPPL-6 Labeling

Label is not available on this site.

10/20/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/20/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/23/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/23/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

BETAMETHASONE VALERATE

CREAM;TOPICAL; EQ 0.1% BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETA-VAL BETAMETHASONE VALERATE EQ 0.1% BASE CREAM;TOPICAL Prescription No AB 018642 COSETTE
BETAMETHASONE VALERATE BETAMETHASONE VALERATE EQ 0.1% BASE CREAM;TOPICAL Prescription Yes AB 018861 FOUGERA PHARMS INC
DERMABET BETAMETHASONE VALERATE EQ 0.1% BASE CREAM;TOPICAL Prescription No AB 072041 TARO
VALNAC BETAMETHASONE VALERATE EQ 0.1% BASE CREAM;TOPICAL Prescription No AB 070050 ACTAVIS MID ATLANTIC

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