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FDA NDA · NDA019443

SODIUM BICARBONATE IN PLASTIC CONTAINER

Sponsor: ABBOTT

APPLICATION
NDA019443
TYPE
NDA
ORIGINAL APPROVAL
1986-06-03
LATEST ACTION
1986-06-03
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

SODIUM BICARBONATE IN PLASTIC CONTAINER · ReferenceDiscontinued
SODIUM BICARBONATE 50MEQ/50ML (1MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
SODIUM BICARBONATE IN PLASTIC CONTAINER · ReferenceDiscontinued
SODIUM BICARBONATE 44.6MEQ/50ML (0.9MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS

Approval history

1986-06-03Type 5 - New Formulation or New Manufacturer · Original · standardAP
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