Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072041
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DERMABET 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
01/06/1988 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
03/22/2017 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

09/27/2004 SUPPL-11 Labeling

Label is not available on this site.

07/11/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/20/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/23/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/17/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/14/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/24/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/09/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DERMABET

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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