APPLICATION
ANDA211825
TYPE
ANDA
ORIGINAL APPROVAL
2019-08-09
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRAMADOL HYDROCHLORIDEPrescription
TRAMADOL HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 22AP
2026-02-13Labeling · Supplement 16 · standardAP
2026-02-13Labeling · Supplement 21 · standardAP
2024-10-31REMS · Supplement 15AP
2023-12-15Labeling · Supplement 14 · standardAP
2023-12-15Labeling · Supplement 13 · standardAP
2023-11-30Labeling · Supplement 12 · standardAP
2023-11-30Labeling · Supplement 5 · standardAP
2023-11-30Labeling · Supplement 8 · standardAP
2020-05-11Labeling · Supplement 2 · 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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