Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072511
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription AT 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
02/07/1989 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-11 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

02/17/2000 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/31/1996 SUPPL-8 Labeling

Label is not available on this site.

07/31/1996 SUPPL-7 Labeling

Label is not available on this site.

05/04/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/04/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

FLUOCINONIDE

SOLUTION;TOPICAL; 0.05%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 071535 ACP NIMBLE
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 209699 ENCUBE ETHICALS
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 072934 FOUGERA PHARMS INC
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 209118 GLASSHOUSE PHARMS
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 209283 MACLEODS PHARMS LTD
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 206003 NOVEL LABS INC
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 074799 TARO
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 207554 TELIGENT PHARMA INC
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 072511 TEVA
FLUOCINONIDE FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription No AT 208948 ZYDUS PHARMS
LIDEX FLUOCINONIDE 0.05% SOLUTION;TOPICAL Prescription Yes AT 018849 CNTY LINE PHARMS

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