APPLICATION
NDA061015
TYPE
NDA
ORIGINAL APPROVAL
1965-07-08
LATEST ACTION
2004-10-25
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
TERRAMYCIN W/ POLYMYXIN B SULFATEDiscontinued
OXYTETRACYCLINE HYDROCHLORIDE EQ 5MG BASE/GM, POLYMYXIN B SULFATE 10,000 UNITS/GM · OINTMENT · OPHTHALMIC
Approval history
2004-10-25Labeling · Supplement 6AP
2000-03-22Manufacturing (CMC) · Supplement 5AP
1999-04-01Manufacturing (CMC) · Supplement 3AP
1999-04-01Manufacturing (CMC) · Supplement 4AP
1998-02-06Manufacturing (CMC) · Supplement 2AP
1997-01-14Manufacturing (CMC) · Supplement 1AP
1965-07-08OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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