APPLICATION
ANDA083173
TYPE
ANDA
ORIGINAL APPROVAL
1975-09-17
LATEST ACTION
2021-04-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LIDOCAINE HYDROCHLORIDEPrescription
LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE · ReferencePrescription
LIDOCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION
Approval history
2021-04-21Labeling · Supplement 45 · standardAP
2005-09-01Labeling · Supplement 36AP
2002-09-19Manufacturing (CMC) · Supplement 37AP
2001-04-06Labeling · Supplement 34AP
1998-01-14Manufacturing (CMC) · Supplement 30AP
1995-09-19Manufacturing (CMC) · Supplement 33AP
1994-06-17Manufacturing (CMC) · Supplement 32AP
1994-06-01Manufacturing (CMC) · Supplement 31AP
1993-10-29Manufacturing (CMC) · Supplement 29AP
1993-10-19Labeling · Supplement 14AP
1993-07-08Labeling · Supplement 26AP
1993-07-08Manufacturing (CMC) · Supplement 25AP
1993-04-30Labeling · Supplement 28AP
1993-02-08Manufacturing (CMC) · Supplement 24AP
1992-12-23Labeling · Supplement 18AP
1992-12-23Manufacturing (CMC) · Supplement 19AP
1992-12-17Manufacturing (CMC) · Supplement 27AP
1992-10-27Manufacturing (CMC) · Supplement 22AP
1991-11-26Manufacturing (CMC) · Supplement 20AP
1991-06-20Labeling · Supplement 21AP
1987-07-10Manufacturing (CMC) · Supplement 13AP
1987-06-16Manufacturing (CMC) · Supplement 10AP
1986-05-16Manufacturing (CMC) · Supplement 7AP
1986-03-11Manufacturing (CMC) · Supplement 8AP
1975-09-17OriginalAP
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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