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FDA ANDA · ANDA206706

TRAMADOL HYDROCHLORIDE

Sponsor: PURACAP LABS BLU

APPLICATION
ANDA206706
TYPE
ANDA
ORIGINAL APPROVAL
2019-07-02
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TRAMADOL HYDROCHLORIDEDiscontinued
TRAMADOL HYDROCHLORIDE 50MG · TABLET · ORAL

Approval history

2025-12-22Labeling · Supplement 3 · standardAP
2024-01-24Labeling · Supplement 2 · standardAP
2024-01-24Labeling · Supplement 1 · standardAP
2019-07-02UNKNOWN · Original · standard — REMS ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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