APPLICATION
ANDA080658
TYPE
ANDA
ORIGINAL APPROVAL
1974-04-01
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PROCAINE HYDROCHLORIDEDiscontinued
PROCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
PROCAINE HYDROCHLORIDEDiscontinued
PROCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 21AP
1999-02-02Manufacturing (CMC) · Supplement 20AP
1997-04-10Manufacturing (CMC) · Supplement 18AP
1996-08-26Manufacturing (CMC) · Supplement 19AP
1994-09-27Labeling · Supplement 14AP
1994-09-27Labeling · Supplement 15AP
1992-01-27Manufacturing (CMC) · Supplement 16AP
1992-01-27Manufacturing (CMC) · Supplement 17AP
1988-12-23Manufacturing (CMC) · Supplement 12AP
1988-12-23Manufacturing (CMC) · Supplement 11AP
1986-07-25Manufacturing (CMC) · Supplement 7AP
1974-04-01OriginalAP
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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