Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 050368
Company: DISTA

Products on NDA 050368

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ILOTYCIN	ERYTHROMYCIN	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050368

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/1964	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Note
07/13/1988	SUPPL-41	Manufacturing (CMC)	Label is not available on this site.
06/28/1982	SUPPL-40	Manufacturing (CMC)	Label is not available on this site.
12/23/1981	SUPPL-39	Manufacturing (CMC)-Control	Label is not available on this site.
02/11/1981	SUPPL-38	Manufacturing (CMC)-Control	Label is not available on this site.
03/24/1981	SUPPL-37	Labeling	Label is not available on this site.
01/22/1981	SUPPL-36	Labeling	Label is not available on this site.
10/21/1980	SUPPL-35	Labeling	Label is not available on this site.
02/06/1980	SUPPL-34	Manufacturing (CMC)-Control	Label is not available on this site.
01/31/1980	SUPPL-33	Manufacturing (CMC)-Control	Label is not available on this site.
02/14/1979	SUPPL-32	Manufacturing (CMC)-Control	Label is not available on this site.
03/06/1978	SUPPL-31	Manufacturing (CMC)-Control	Label is not available on this site.
01/21/1977	SUPPL-30	Manufacturing (CMC)-Control	Label is not available on this site.
03/26/1976	SUPPL-29	Labeling	Label is not available on this site.
03/26/1976	SUPPL-28	Labeling	Label is not available on this site.
01/29/1976	SUPPL-27	Manufacturing (CMC)-Control	Label is not available on this site.
09/09/1975	SUPPL-26	Labeling	Label is not available on this site.
01/28/1975	SUPPL-25	Manufacturing (CMC)-Control	Label is not available on this site.
07/23/1974	SUPPL-24	Labeling	Label is not available on this site.
11/12/1973	SUPPL-23	Manufacturing (CMC)-Control	Label is not available on this site.
02/16/1973	SUPPL-22	Manufacturing (CMC)-Control	Label is not available on this site.
11/22/1972	SUPPL-21	Manufacturing (CMC)-Control	Label is not available on this site.
10/31/1972	SUPPL-20	Labeling	Label is not available on this site.
11/03/1972	SUPPL-19	Labeling	Label is not available on this site.
12/01/1971	SUPPL-18	Manufacturing (CMC)-Control	Label is not available on this site.
12/15/1970	SUPPL-17	Manufacturing (CMC)-Control	Label is not available on this site.
12/15/1969	SUPPL-16	Manufacturing (CMC)-Control	Label is not available on this site.
05/09/1969	SUPPL-15	Labeling	Label is not available on this site.
04/28/1969	SUPPL-14	Manufacturing (CMC)	Label is not available on this site.
02/11/1969	SUPPL-13	Manufacturing (CMC)	Label is not available on this site.
01/16/1969	SUPPL-12	Manufacturing (CMC)-Control	Label is not available on this site.
05/17/1967	SUPPL-11	Labeling	Label is not available on this site.
07/14/1993	SUPPL-10	Labeling	Label is not available on this site.
07/14/1993	SUPPL-9	Labeling	Label is not available on this site.
05/22/1987	SUPPL-8	Labeling	Label is not available on this site.
05/03/1967	SUPPL-7	Efficacy-New Dosing Regimen	Label is not available on this site.
04/15/1986	SUPPL-6	Manufacturing (CMC)-Formulation	Label is not available on this site.
03/10/1986	SUPPL-5	Labeling	Label is not available on this site.
01/14/1966	SUPPL-4	Manufacturing (CMC)-Expiration Date	Label is not available on this site.
03/27/1985	SUPPL-3	Manufacturing (CMC)-Control	Label is not available on this site.
03/06/1984	SUPPL-2	Manufacturing (CMC)-Packaging	Label is not available on this site.
12/28/1982	SUPPL-1	Manufacturing (CMC)-Control	Label is not available on this site.