APPLICATION
ANDA216184
TYPE
ANDA
ORIGINAL APPROVAL
2023-08-02
LATEST ACTION
2024-11-21
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Prescription
Products
INDOMETHACINPrescription
INDOMETHACIN 50MG · SUPPOSITORY · RECTAL
Approval history
2024-11-21Labeling · Supplement 3 · standardAP
2023-08-02UNKNOWN · 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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