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ANDA218862

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL EU LTD · Approved 2025-01-16

Drug application

FDA Application #
ANDA218862
Application type
Abbreviated New Drug Application (Generic)
Brand name
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Generic name
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Active ingredients
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Dosage form
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Route
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Marketing status
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Sponsor
AMNEAL EU LTD
First approval
2025-01-16

Source

Authoritative
Drugs@FDA application overview
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