Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071500
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription AB1 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
06/10/1987 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
08/14/2001 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

09/30/1993 SUPPL-19 Labeling

Label is not available on this site.

02/26/1993 SUPPL-18 Labeling

Label is not available on this site.

01/25/1993 SUPPL-17 Labeling

Label is not available on this site.

12/31/1990 SUPPL-15 Labeling

Label is not available on this site.

09/21/1989 SUPPL-13 Labeling

Label is not available on this site.

09/13/1990 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/27/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/26/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/02/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/03/1988 SUPPL-7 Labeling

Label is not available on this site.

07/08/1988 SUPPL-6 Labeling

Label is not available on this site.

07/08/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/08/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/10/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/10/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/24/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

FLUOCINONIDE

CREAM;TOPICAL; 0.05%
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 073085 ACP NIMBLE
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 073030 FOUGERA PHARMS INC
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription Yes AB1 019117 TARO
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 071500 TARO
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 211410 TELIGENT PHARMA INC
FLUOCINONIDE FLUOCINONIDE 0.05% CREAM;TOPICAL Prescription No AB1 072488 TEVA

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