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BALSALAZIDE DISODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS LIFESCIENCES · Approved 2023-06-08

Drug application

FDA Application #
ANDA217592
Application type
Abbreviated New Drug Application (Generic)
Brand name
BALSALAZIDE DISODIUM
Generic name
BALSALAZIDE DISODIUM
Active ingredients
BALSALAZIDE DISODIUM
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
ZYDUS LIFESCIENCES
Manufacturer
Zydus Lifesciences Limited
First approval
2023-06-08

Source

Authoritative
Drugs@FDA application overview
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