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MESALAMINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2022-10-28

Drug application

FDA Application #
ANDA216967
Application type
Abbreviated New Drug Application (Generic)
Brand name
MESALAMINE
Generic name
MESALAMINE
Active ingredients
MESALAMINE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
ALEMBIC
Manufacturer
Alembic Pharmaceuticals Limited
First approval
2022-10-28

Source

Authoritative
Drugs@FDA application overview
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