Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 015296
Company: MEDIMETRIKS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYNALAR FLUOCINOLONE ACETONIDE 0.01% SOLUTION;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
05/27/1964 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/19/2012 SUPPL-64 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/015296s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/015296Orig1s064ltr.pdf
11/16/2012 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

09/26/2000 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

07/22/1996 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

03/02/1995 SUPPL-56 Labeling

Label is not available on this site.

11/13/1992 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1992 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1995 SUPPL-53 Labeling

Label is not available on this site.

02/13/1990 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

12/19/1989 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

12/19/1989 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

02/10/1989 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1985 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1984 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

09/07/1983 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

06/23/1983 SUPPL-44 Labeling

Label is not available on this site.

11/19/1982 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

11/20/1981 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

11/16/1981 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1981 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/19/1981 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/19/1981 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/19/1981 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/03/1981 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/19/1980 SUPPL-34 Labeling

Label is not available on this site.

10/23/1979 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/13/1979 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

11/28/1978 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1979 SUPPL-30 Labeling

Label is not available on this site.

03/14/1979 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1978 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1978 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/1977 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/1977 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1977 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/12/1976 SUPPL-21 Labeling

Label is not available on this site.

01/07/1976 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/19/2012 SUPPL-64 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/015296s064lbl.pdf

SYNALAR

SOLUTION;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% SOLUTION;TOPICAL Prescription No AT 209913 ENCUBE ETHICALS
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% SOLUTION;TOPICAL Prescription No AT 088167 FOUGERA PHARMS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% SOLUTION;TOPICAL Prescription No AT 209596 GLASSHOUSE PHARMS
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% SOLUTION;TOPICAL Prescription No AT 206422 LUPIN
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% SOLUTION;TOPICAL Prescription No AT 089124 TARO
SYNALAR FLUOCINOLONE ACETONIDE 0.01% SOLUTION;TOPICAL Prescription Yes AT 015296 MEDIMETRIKS PHARMS

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