APPLICATION
ANDA064210
TYPE
ANDA
ORIGINAL APPROVAL
1998-06-30
LATEST ACTION
2023-02-10
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
STREPTOMYCIN SULFATEPrescription
STREPTOMYCIN SULFATE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2023-02-10Labeling · Supplement 16 · standardAP
2015-11-10Labeling · Supplement 12 · standardAP
2001-07-23Manufacturing (CMC) · Supplement 2AP
2001-07-23Manufacturing (CMC) · Supplement 3AP
2000-05-11Manufacturing (CMC) · Supplement 1AP
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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