Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 012787
Company: MEDIMETRIKS PHARMS
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 088169 FOUGERA PHARMS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 210747 G AND W LABS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 087104 TARO
SYNALAR FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription Yes AT 012787 MEDIMETRIKS PHARMS

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 088170 FOUGERA PHARMS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% CREAM;TOPICAL Prescription No AT 089526 G AND W LABS
SYNALAR FLUOCINOLONE ACETONIDE 0.01% CREAM;TOPICAL Prescription Yes AT 012787 MEDIMETRIKS PHARMS

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 088169 FOUGERA PHARMS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 210747 G AND W LABS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription No AT 087104 TARO
SYNALAR FLUOCINOLONE ACETONIDE 0.025% CREAM;TOPICAL Prescription Yes AT 012787 MEDIMETRIKS PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English