APPLICATION
ANDA217883
TYPE
ANDA
ORIGINAL APPROVAL
2024-01-12
LATEST ACTION
2025-06-02
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
INDOMETHACINPrescription
INDOMETHACIN 25MG/5ML · SUSPENSION · ORAL
Approval history
2025-06-02Labeling · Supplement 5 · standardAP
2024-01-12UNKNOWN · Original · standardAP
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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