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FDA ANDA · ANDA074768

ATRACURIUM BESYLATE PRESERVATIVE FREE

Sponsor: BAXTER HLTHCARE CORP

APPLICATION
ANDA074768
TYPE
ANDA
ORIGINAL APPROVAL
1997-01-23
LATEST ACTION
2000-02-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ATRACURIUM BESYLATE PRESERVATIVE FREEDiscontinued
ATRACURIUM BESYLATE 10MG/ML · INJECTABLE · INJECTION

Approval history

2000-02-17Manufacturing (CMC) · Supplement 6AP
2000-02-17Manufacturing (CMC) · Supplement 5AP
1999-11-22Manufacturing (CMC) · Supplement 4AP
1999-11-22Manufacturing (CMC) · Supplement 2AP
1999-11-22Manufacturing (CMC) · Supplement 3AP
1997-07-22Labeling · Supplement 1AP
1997-01-23OriginalAP
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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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