APPLICATION
ANDA060111
TYPE
ANDA
ORIGINAL APPROVAL
1952-02-12
LATEST ACTION
1995-01-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
STREPTOMYCIN SULFATEDiscontinued
STREPTOMYCIN SULFATE EQ 1GM BASE/2.5ML · INJECTABLE · INJECTION
Approval history
1995-01-09Manufacturing (CMC) · Supplement 4AP
1993-07-08Labeling · Supplement 3AP
1993-04-23Labeling · Supplement 2AP
1993-04-23Manufacturing (CMC) · Supplement 1AP
1952-02-12OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.