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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075008
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINONIDE FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/30/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75008ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/13/2004 SUPPL-4 Labeling

Label is not available on this site.

03/15/2000 SUPPL-1 Manufacturing (CMC)-Control

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 207680 PAI HOLDINGS PHARM
FLUOCINONIDE FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 075008 TARO
FLUOCINONIDE FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 073481 TEVA
FLUOCINONIDE FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription No AB 212976 XIROMED
LIDEX FLUOCINONIDE 0.05% OINTMENT;TOPICAL Prescription Yes AB 016909 ALVOGEN
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