Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050404
Company: LEDERLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AUREOMYCIN CHLORTETRACYCLINE HYDROCHLORIDE 1% 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
01/23/1950 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/13/1975 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1974 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/08/1974 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/1973 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/10/1973 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/1969 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/01/1963 SUPPL-13 Labeling

Label is not available on this site.

04/06/1961 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1959 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/09/1959 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/01/1958 SUPPL-9 Labeling

Label is not available on this site.

03/11/1952 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/02/1951 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/07/1950 SUPPL-6 Labeling

Label is not available on this site.

12/01/1988 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/31/1950 SUPPL-2 Labeling

Label is not available on this site.

10/26/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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