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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012787
Company: EUROFARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYNALAR FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription AT Yes Yes
SYNALAR FLUOCINOLONE ACETONIDE 0.01% CREAM;TOPICAL Prescription AT Yes Yes
SYNALAR FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription AT Yes 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
02/15/1963 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/28/2013 SUPPL-71 Manufacturing (CMC) Label (PDF)
Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lblrev.pdf
09/26/2000 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.
07/22/1996 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.
03/01/1995 SUPPL-64 Labeling

Label is not available on this site.
11/13/1992 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.
04/24/1992 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.
03/06/1995 SUPPL-61 Labeling

Label is not available on this site.
03/06/1995 SUPPL-60 Labeling

Label is not available on this site.
02/13/1990 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.
04/04/1989 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.
02/10/1989 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.
04/12/1989 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.
12/20/1984 SUPPL-55 Manufacturing (CMC)-Formulation

Label is not available on this site.
08/29/1984 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.
09/07/1983 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.
04/08/1983 SUPPL-52 Labeling

Label is not available on this site.
11/19/1982 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.
11/20/1981 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.
11/12/1981 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.
01/19/1981 SUPPL-47 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/19/1981 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/19/1981 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/19/1981 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/26/1981 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.
07/30/1980 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/19/1980 SUPPL-40 Labeling

Label is not available on this site.
02/19/1980 SUPPL-39 Labeling

Label is not available on this site.
10/23/1979 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.
08/13/1979 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.
07/25/1979 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.
04/13/1979 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.
11/28/1978 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.
09/12/1978 SUPPL-32 Labeling

Label is not available on this site.
01/10/1979 SUPPL-31 Labeling

Label is not available on this site.
06/04/1977 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
01/04/1977 SUPPL-29 Labeling

Label is not available on this site.
07/08/1976 SUPPL-28 Labeling

Label is not available on this site.
12/12/1975 SUPPL-27 Labeling

Label is not available on this site.
06/26/1975 SUPPL-26 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/28/2013 SUPPL-71 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lbl.pdf
03/28/2013 SUPPL-71 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012787s071lblrev.pdf

SYNALAR

CREAM;TOPICAL; 0.025%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 210747 COSETTE PHARMS NC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 088169 FOUGERA PHARMS INC
SYNALAR FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription Yes AT 012787 EUROFARMA

CREAM;TOPICAL; 0.01%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% CREAM;TOPICAL Prescription No AT 089526 COSETTE PHARMS NC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% CREAM;TOPICAL Prescription No AT 088170 FOUGERA PHARMS INC
SYNALAR FLUOCINOLONE ACETONIDE 0.01% CREAM;TOPICAL Prescription Yes AT 012787 EUROFARMA

CREAM;TOPICAL; 0.025%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 210747 COSETTE PHARMS NC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 088169 FOUGERA PHARMS INC
SYNALAR FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription Yes AT 012787 EUROFARMA
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