Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013960
Company: MEDIMETRIKS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYNALAR FLUOCINOLONE ACETONIDE 0.025% OINTMENT;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
06/19/1963 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
09/26/2000 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

03/02/1995 SUPPL-51 Labeling

Label is not available on this site.

11/13/1992 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1992 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1995 SUPPL-48 Labeling

Label is not available on this site.

02/13/1990 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1989 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1985 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1984 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

05/25/1984 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

04/08/1983 SUPPL-42 Labeling

Label is not available on this site.

11/19/1982 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

11/20/1981 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

11/16/1981 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1982 SUPPL-37 Labeling

Label is not available on this site.

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

Label is not available on this site.

01/19/1981 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/19/1981 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/19/1981 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/15/1981 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/07/1980 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/19/1980 SUPPL-30 Labeling

Label is not available on this site.

10/23/1979 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/13/1979 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

11/28/1978 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

01/02/1979 SUPPL-26 Labeling

Label is not available on this site.

10/12/1978 SUPPL-25 Labeling

Label is not available on this site.

06/30/1978 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1978 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/1977 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/1977 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1977 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/04/1977 SUPPL-19 Labeling

Label is not available on this site.

07/15/1976 SUPPL-18 Labeling

Label is not available on this site.

07/16/1975 SUPPL-17 Labeling

Label is not available on this site.

SYNALAR

OINTMENT;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% OINTMENT;TOPICAL Prescription No AT 089524 COSETTE
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% OINTMENT;TOPICAL Prescription No AT 088168 FOUGERA PHARMS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.025% OINTMENT;TOPICAL Prescription No AT 040041 TARO
SYNALAR FLUOCINOLONE ACETONIDE 0.025% OINTMENT;TOPICAL Prescription Yes AT 013960 MEDIMETRIKS PHARMS

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