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FDA ANDA · ANDA075695
BUTORPHANOL TARTRATE PRESERVATIVE FREE
Sponsor: BAXTER HLTHCARE CORP
APPLICATION
ANDA075695
TYPE
ANDA
ORIGINAL APPROVAL
2001-10-23
LATEST ACTION
2019-10-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BUTORPHANOL TARTRATE PRESERVATIVE FREEDiscontinued
BUTORPHANOL TARTRATE 2MG/ML · INJECTABLE · INJECTION
BUTORPHANOL TARTRATE PRESERVATIVE FREEDiscontinued
BUTORPHANOL TARTRATE 1MG/ML · INJECTABLE · INJECTION
Approval history
2019-10-11Labeling · Supplement 23 · standardAP
2016-12-16Labeling · Supplement 22 · standardAP
2016-12-16Labeling · Supplement 21 · standardAP
2008-05-16Manufacturing (CMC) · Supplement 19AP
2002-11-20Manufacturing (CMC) · Supplement 1AP
2001-10-23OriginalAP
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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