APPLICATION
ANDA080377
TYPE
ANDA
ORIGINAL APPROVAL
1974-02-20
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINEDiscontinued
EPINEPHRINE 0.01MG/ML, LIDOCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDEDiscontinued
LIDOCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINEDiscontinued
EPINEPHRINE 0.01MG/ML, LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
LIDOCAINE HYDROCHLORIDEDiscontinued
LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 264AP
1998-04-10Manufacturing (CMC) · Supplement 262AP
1998-02-18Labeling · Supplement 260AP
1997-02-11Manufacturing (CMC) · Supplement 259AP
1997-01-09Labeling · Supplement 257AP
1996-12-04Manufacturing (CMC) · Supplement 258AP
1995-04-17Manufacturing (CMC) · Supplement 256AP
1994-04-19Manufacturing (CMC) · Supplement 255AP
1991-09-13Manufacturing (CMC) · Supplement 253AP
1991-03-18Labeling · Supplement 254AP
1990-06-06Labeling · Supplement 252AP
1989-07-03Bioequivalence · Supplement 251AP
1989-05-05Manufacturing (CMC) · Supplement 249AP
1986-08-15Manufacturing (CMC) · Supplement 243AP
1986-07-17Manufacturing (CMC) · Supplement 244AP
1984-01-23Manufacturing (CMC) · Supplement 242AP
1984-01-23Manufacturing (CMC) · Supplement 240AP
1982-05-27Manufacturing (CMC) · Supplement 239AP
1982-04-30Manufacturing (CMC) · Supplement 238AP
1974-02-20OriginalAP
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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