← FDA DRUG APPROVALS

FDA ANDA · ANDA076453

LIDOCAINE AND PRILOCAINE

Sponsor: FOUGERA PHARMS

APPLICATION
ANDA076453
TYPE
ANDA
ORIGINAL APPROVAL
2003-08-18
LATEST ACTION
2004-07-21
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

LIDOCAINE AND PRILOCAINEPrescription
LIDOCAINE 2.5%, PRILOCAINE 2.5% · CREAM · TOPICAL

Approval history

2004-07-21Labeling · Supplement 5 — Review ↗AP
2004-07-21Supplement · Supplement 3 — Review ↗AP
2004-07-21Supplement · Supplement 4 — Review ↗AP
2004-06-14Supplement · Supplement 1 — Review ↗AP
2004-01-21Supplement · Supplement 2 — Review ↗AP
2003-08-18Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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