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FDA ANDA · ANDA071810
BUPIVACAINE SPINAL
bupivacaine hydrochloride in dextrose
Sponsor: HOSPIRA
APPLICATION
ANDA071810
TYPE
ANDA
ORIGINAL APPROVAL
1987-12-11
LATEST ACTION
2020-06-09
ROUTE
SUBARACHNOID, SPINAL
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
BUPIVACAINE HYDROCHLORIDEPrescription
BUPIVACAINE HYDROCHLORIDE 0.75% · INJECTABLE · SPINAL
Approval history
2020-06-09Labeling · Supplement 21 · standardAP
2015-08-25Labeling · Supplement 17 · standardAP
2010-04-07Labeling · Supplement 14AP
1997-07-15Labeling · Supplement 8AP
1996-08-08Manufacturing (CMC) · Supplement 7AP
1996-06-20Manufacturing (CMC) · Supplement 2AP
1995-11-02Manufacturing (CMC) · Supplement 6AP
1995-02-23Manufacturing (CMC) · Supplement 3AP
1987-12-11OriginalAP
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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