APPLICATION
ANDA080416
TYPE
ANDA
ORIGINAL APPROVAL
1972-09-15
LATEST ACTION
2000-05-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PROCAINE HYDROCHLORIDEDiscontinued
PROCAINE HYDROCHLORIDE 1% · INJECTABLE · INJECTION
PROCAINE HYDROCHLORIDEDiscontinued
PROCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
Approval history
2000-05-15Manufacturing (CMC) · Supplement 34AP
2000-03-02Manufacturing (CMC) · Supplement 33AP
1998-07-20Manufacturing (CMC) · Supplement 31AP
1998-07-20Manufacturing (CMC) · Supplement 32AP
1997-10-21Manufacturing (CMC) · Supplement 30AP
1996-10-22Manufacturing (CMC) · Supplement 28AP
1996-10-03Manufacturing (CMC) · Supplement 29AP
1994-06-20Manufacturing (CMC) · Supplement 26AP
1989-08-03Labeling · Supplement 25AP
1988-04-21Labeling · Supplement 24AP
1987-05-06Manufacturing (CMC) · Supplement 23AP
1982-09-14Manufacturing (CMC) · Supplement 21AP
1972-09-15OriginalAP
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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