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FDA ANDA · ANDA071168

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Sponsor: HOSPIRA

APPLICATION
ANDA071168
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-16
LATEST ACTION
2021-07-06
ROUTE
EPIDURAL, INTRACAUDAL, PERINEURAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEPrescription
BUPIVACAINE HYDROCHLORIDE 0.5%, EPINEPHRINE 0.005MG/ML · INJECTABLE · INJECTION

Approval history

2021-07-06Labeling · Supplement 42 · standardAP
2020-12-09Labeling · Supplement 29 · standardAP
2020-12-09Labeling · Supplement 31 · standardAP
2020-12-09Labeling · Supplement 38 · standardAP
2010-02-19Labeling · Supplement 20 — Label ↗AP
2002-12-20Manufacturing (CMC) · Supplement 10AP
1999-11-22Labeling · Supplement 9AP
1997-09-26Manufacturing (CMC) · Supplement 7AP
1997-07-29Manufacturing (CMC) · Supplement 8AP
1991-02-21Manufacturing (CMC) · Supplement 3AP
1991-02-21Manufacturing (CMC) · Supplement 1AP
1991-02-21Manufacturing (CMC) · Supplement 2AP
1990-10-03Labeling · Supplement 5AP
1990-05-04Labeling · Supplement 4AP
1988-06-16OriginalAP
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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