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FDA ANDA · ANDA078826

LORAZEPAM

Sponsor: AMNEAL PHARMS

APPLICATION
ANDA078826
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-23
LATEST ACTION
2012-08-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LORAZEPAMDiscontinued
LORAZEPAM 2MG · TABLET · ORAL
LORAZEPAMDiscontinued
LORAZEPAM 0.5MG · TABLET · ORAL
LORAZEPAMDiscontinued
LORAZEPAM 1MG · TABLET · ORAL

Approval history

2012-08-10Manufacturing (CMC) · Supplement 1AP
2010-06-23OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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