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FDA ANDA · ANDA078084
METRONIDAZOLE IN PLASTIC CONTAINER
Sponsor: BAXTER HLTHCARE CORP
APPLICATION
ANDA078084
TYPE
ANDA
ORIGINAL APPROVAL
2008-03-31
LATEST ACTION
2019-11-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
METRONIDAZOLE IN PLASTIC CONTAINERDiscontinued
METRONIDAZOLE 500MG/100ML · INJECTABLE · INJECTION
Approval history
2019-11-08Labeling · Supplement 14 · standardAP
2019-11-08Labeling · Supplement 11 · standardAP
2012-03-28Labeling · Supplement 8AP
2011-04-07Labeling · Supplement 2AP
2010-01-08Labeling · Supplement 5AP
2009-11-13Labeling · Supplement 4AP
2009-01-15Labeling · Supplement 3AP
2008-03-31OriginalAP
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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