Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050368
Company: DISTA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ILOTYCIN ERYTHROMYCIN 0.5% OINTMENT;OPHTHALMIC Discontinued None No No
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 Letters, Reviews, Labels, Patient Package Insert Note Url
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.

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