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FDA NDA · NDA017702

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

Sponsor: INTL MEDICATION

APPLICATION
NDA017702
TYPE
NDA
ORIGINAL APPROVAL
1976-12-20
LATEST ACTION
1995-10-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREEDiscontinued
LIDOCAINE HYDROCHLORIDE 4% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREEDiscontinued
LIDOCAINE HYDROCHLORIDE 20% · INJECTABLE · INJECTION

Approval history

1995-10-18Manufacturing (CMC) · Supplement 25 · standardAP
1993-10-06Labeling · Supplement 24 · standardAP
1993-05-17Manufacturing (CMC) · Supplement 12 · standardAP
1993-02-17Manufacturing (CMC) · Supplement 19 · standardAP
1992-12-14Manufacturing (CMC) · Supplement 18 · standardAP
1992-12-11Manufacturing (CMC) · Supplement 21 · standardAP
1992-11-06Manufacturing (CMC) · Supplement 20 · standardAP
1992-06-12Manufacturing (CMC) · Supplement 14 · standardAP
1992-06-11Manufacturing (CMC) · Supplement 17 · standardAP
1986-06-26Labeling · Supplement 10AP
1978-07-11Manufacturing (CMC) · Supplement 3 · standardAP
1978-07-11Labeling · Supplement 4AP
1977-08-24Manufacturing (CMC) · Supplement 1 · standardAP
1977-08-24Labeling · Supplement 2AP
1976-12-20Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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