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FDA ANDA · ANDA080407

LIDOCAINE

lidocaine hydrochloride

Sponsor: WEST-WARD PHARMS INT

APPLICATION
ANDA080407
TYPE
ANDA
ORIGINAL APPROVAL
1972-02-14
LATEST ACTION
2020-02-20
ROUTE
INFILTRATION, PERINEURAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LIDOCAINE HYDROCHLORIDEPrescription
LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDEPrescription
LIDOCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION

Approval history

2020-02-20Labeling · Supplement 99 · standardAP
2020-02-20Labeling · Supplement 98 · standardAP
2001-01-29Labeling · Supplement 95AP
2000-10-25Manufacturing (CMC) · Supplement 94AP
1998-11-02Manufacturing (CMC) · Supplement 93AP
1997-02-04Manufacturing (CMC) · Supplement 90AP
1996-04-10Manufacturing (CMC) · Supplement 89AP
1996-02-13Manufacturing (CMC) · Supplement 88AP
1992-01-29Manufacturing (CMC) · Supplement 85AP
1992-01-29Manufacturing (CMC) · Supplement 86AP
1991-07-18Labeling · Supplement 87AP
1990-03-20Labeling · Supplement 84AP
1989-05-12Labeling · Supplement 83AP
1989-05-12Manufacturing (CMC) · Supplement 82AP
1988-06-14Labeling · Supplement 81AP
1987-12-22Manufacturing (CMC) · Supplement 80AP
1986-11-03Manufacturing (CMC) · Supplement 78AP
1985-11-21Manufacturing (CMC) · Supplement 77AP
1983-01-21Manufacturing (CMC) · Supplement 73AP
1982-09-30Manufacturing (CMC) · Supplement 74AP
1982-08-04Manufacturing (CMC) · Supplement 72AP
1972-02-14OriginalAP
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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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