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FDA NDA · NDA018053

BUPIVACAINE HYDROCHLORIDE

Sponsor: HOSPIRA

APPLICATION
NDA018053
TYPE
NDA
ORIGINAL APPROVAL
1978-04-17
LATEST ACTION
2021-03-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

BUPIVACAINE HYDROCHLORIDEDiscontinued
BUPIVACAINE HYDROCHLORIDE 0.75% · INJECTABLE · INJECTION
BUPIVACAINE HYDROCHLORIDEDiscontinued
BUPIVACAINE HYDROCHLORIDE 0.5% · INJECTABLE · INJECTION
BUPIVACAINE HYDROCHLORIDEDiscontinued
BUPIVACAINE HYDROCHLORIDE 0.25% · INJECTABLE · INJECTION

Approval history

2021-03-09Labeling · Supplement 61 · standard — Letter ↗AP
2018-11-02Labeling · Supplement 60 · standard — Label ↗AP
2016-01-11Manufacturing (CMC) · Supplement 57AP
2015-07-10Labeling · Supplement 55 · standard — Label ↗AP
2014-05-06Manufacturing (CMC) · Supplement 56AP
2010-04-07Labeling · Supplement 52AP
2002-08-29Manufacturing (CMC) · Supplement 44AP
1999-11-02Labeling · Supplement 43AP
1999-04-07Manufacturing (CMC) · Supplement 42AP
1997-02-24Manufacturing (CMC) · Supplement 40AP
1996-11-04Manufacturing (CMC) · Supplement 38AP
1996-11-04Manufacturing (CMC) · Supplement 39AP
1992-01-29Manufacturing (CMC) · Supplement 35AP
1991-12-11Labeling · Supplement 36AP
1991-02-15Labeling · Supplement 33AP
1990-05-04Labeling · Supplement 34AP
1988-04-07Manufacturing (CMC) · Supplement 31AP
1978-04-17OriginalAP
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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