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FDA ANDA · ANDA064021

TOBRAMYCIN SULFATE

Sponsor: APOTHECON

APPLICATION
ANDA064021
TYPE
ANDA
ORIGINAL APPROVAL
1994-05-31
LATEST ACTION
2002-08-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

TOBRAMYCIN SULFATEDiscontinued
TOBRAMYCIN SULFATE EQ 10MG BASE/ML · INJECTABLE · INJECTION
TOBRAMYCIN SULFATEDiscontinued
TOBRAMYCIN SULFATE EQ 40MG BASE/ML · INJECTABLE · INJECTION

Approval history

2002-08-06Manufacturing (CMC) · Supplement 4AP
1996-08-26Manufacturing (CMC) · Supplement 2AP
1995-03-10Manufacturing (CMC) · Supplement 1AP
1994-05-31OriginalAP
VIEW ON DRUGS@FDA ↗

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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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