Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201759
Company: IDENTI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;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
10/17/2011 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/201759Orig1s000.pdf

FLUOCINOLONE ACETONIDE

OIL;TOPICAL; 0.01%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription Yes AT 019452 HILL DERMAC
FLUCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 210556 GLENMARK PHARMS LTD
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 091514 AKORN
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 201759 IDENTI PHARMS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 201764 IDENTI PHARMS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 090982 LYNE
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 203377 LYNE
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 202847 PERRIGO ISRAEL
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 202848 PERRIGO ISRAEL
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 202368 TARO
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 209336 TARO
FLUOCINONIDE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 210539 GLENMARK PHARMS LTD

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