Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 013960
Company: MEDIMETRIKS PHARMS

Products on NDA 013960

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 013960

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	Note
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.

Therapeutic Equivalents for NDA 013960

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