APPLICATION
ANDA077806
TYPE
ANDA
ORIGINAL APPROVAL
2007-12-28
LATEST ACTION
2024-02-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
BALSALAZIDE DISODIUMPrescription
BALSALAZIDE DISODIUM 750MG · CAPSULE · ORAL
Approval history
2024-02-16Labeling · Supplement 9 · standardAP
2023-08-08Labeling · Supplement 8 · standardAP
2023-08-08Labeling · Supplement 7 · standardAP
2021-07-30Labeling · Supplement 6 · standardAP
2021-07-30Labeling · Supplement 5 · standardAP
2012-11-13Labeling · Supplement 2AP
2007-12-28OriginalAP
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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