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FDA ANDA · ANDA089409
POLOCAINE-MPF
mepivacaine hydrochloride
Sponsor: FRESENIUS KABI USA
APPLICATION
ANDA089409
TYPE
ANDA
ORIGINAL APPROVAL
1986-12-01
LATEST ACTION
2025-01-29
ROUTE
EPIDURAL, INFILTRATION, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
POLOCAINE-MPFPrescription
MEPIVACAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION
Approval history
2025-01-29Labeling · Supplement 21 · standardAP
2025-01-29Labeling · Supplement 26 · standardAP
2010-06-15Labeling · Supplement 15AP
2002-05-24Labeling · Supplement 13AP
2002-03-08Manufacturing (CMC) · Supplement 11AP
2001-03-30Manufacturing (CMC) · Supplement 10AP
2000-03-21Manufacturing (CMC) · Supplement 8AP
1996-11-26Manufacturing (CMC) · Supplement 7AP
1996-05-31Manufacturing (CMC) · Supplement 6AP
1994-12-27Manufacturing (CMC) · Supplement 5AP
1992-09-18Manufacturing (CMC) · Supplement 4AP
1992-03-18Labeling · Supplement 3AP
1986-12-01OriginalAP
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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