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FDA ANDA · ANDA076045

LORAZEPAM

Sponsor: SUN PHARM INDS LTD

APPLICATION
ANDA076045
TYPE
ANDA
ORIGINAL APPROVAL
2001-08-29
LATEST ACTION
2009-06-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2009-06-29Labeling · Supplement 7AP
2001-08-29OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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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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