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FDA ANDA · ANDA062730

CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER

Sponsor: BAXTER HLTHCARE

APPLICATION
ANDA062730
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-05
LATEST ACTION
1992-11-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINERDiscontinued
CEPHALOTHIN SODIUM EQ 40MG BASE/ML · INJECTABLE · INJECTION
CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINERDiscontinued
CEPHALOTHIN SODIUM EQ 20MG BASE/ML · INJECTABLE · INJECTION

Approval history

1992-11-12Labeling · Supplement 2AP
1992-03-25Labeling · Supplement 1AP
1987-03-05OriginalAP
VIEW ON DRUGS@FDA ↗

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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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