Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073481
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINONIDE FLUOCINONIDE 0.05% 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
12/27/1991 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
10/26/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/2001 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

12/23/1999 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/31/1996 SUPPL-9 Labeling

Label is not available on this site.

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

Label is not available on this site.

09/24/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/24/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/14/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/23/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/24/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/08/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

FLUOCINONIDE

OINTMENT;TOPICAL; 0.05%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINONIDE FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 074905 FOUGERA PHARMS
FLUOCINONIDE FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 207538 NOVEL LABS INC
FLUOCINONIDE FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 075008 TARO
FLUOCINONIDE FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 207680 TELIGENT PHARMA INC
FLUOCINONIDE FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 073481 TEVA
LIDEX FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription Yes AB 016909 CNTY LINE PHARMS

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