Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070050
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VALNAC BETAMETHASONE VALERATE EQ 0.1% BASE CREAM;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
10/10/1984 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
05/30/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/13/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/13/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/13/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/13/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/07/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/22/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/22/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/29/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/11/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/13/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

VALNAC

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 ACP NIMBLE
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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