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FDA ANDA · ANDA075720

METIPRANOLOL

Sponsor: SANDOZ

APPLICATION
ANDA075720
TYPE
ANDA
ORIGINAL APPROVAL
2001-08-06
LATEST ACTION
2002-12-23
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

METIPRANOLOLDiscontinued
METIPRANOLOL HYDROCHLORIDE 0.3% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2002-12-23Manufacturing (CMC) · Supplement 3AP
2002-10-01Manufacturing (CMC) · Supplement 2AP
2002-03-22Manufacturing (CMC) · Supplement 1AP
2001-08-06OriginalAP
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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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