Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070069
Company: COSETTE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BETA-VAL BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT;TOPICAL Prescription AB 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
12/19/1985 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
08/30/2001 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

06/13/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/13/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/25/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/18/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/14/1988 SUPPL-2 Labeling

Label is not available on this site.

02/14/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

BETA-VAL

OINTMENT;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 OINTMENT;TOPICAL Prescription No AB 070069 COSETTE
BETAMETHASONE VALERATE BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT;TOPICAL Prescription No AB 070051 ACTAVIS MID ATLANTIC
BETAMETHASONE VALERATE BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT;TOPICAL Prescription Yes AB 018865 FOUGERA PHARMS INC

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