APPLICATION
NDA019228
TYPE
NDA
ORIGINAL APPROVAL
1987-05-05
LATEST ACTION
1994-04-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
MANGANESE SULFATE · ReferenceDiscontinued
MANGANESE SULFATE EQ 0.1MG MANGANESE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1994-04-25Labeling · Supplement 5 · standardAP
1992-06-09Labeling · Supplement 3AP
1989-06-07Labeling · Supplement 1AP
1987-05-05Type 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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