APPLICATION
NDA006170
TYPE
NDA
ORIGINAL APPROVAL
1947-04-23
LATEST ACTION
1984-01-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HYPROTIGEN 5%Discontinued
PROTEIN HYDROLYSATE 5% · INJECTABLE · INJECTION
Approval history
1984-01-10Manufacturing (CMC) · Supplement 6 · standardAP
1984-01-10Efficacy · Supplement 4 · standardAP
1984-01-10Labeling · Supplement 5 · standardAP
1947-04-23Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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