← FDA DRUG APPROVALS

FDA NDA · NDA022370

TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE

tramadol hydrochloride

Sponsor: CIPHER PHARMS INC

APPLICATION
NDA022370
TYPE
NDA
ORIGINAL APPROVAL
2010-05-07
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued, Prescription

Products

CONZIP · ReferenceDiscontinued
TRAMADOL HYDROCHLORIDE 150MG · CAPSULE, EXTENDED RELEASE · ORAL
CONZIP · ReferencePrescription
TRAMADOL HYDROCHLORIDE 200MG · CAPSULE, EXTENDED RELEASE · ORAL
CONZIP · ReferencePrescription
TRAMADOL HYDROCHLORIDE 300MG · CAPSULE, EXTENDED RELEASE · ORAL
CONZIP · ReferencePrescription
TRAMADOL HYDROCHLORIDE 100MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2026-06-18REMS · Supplement 28 — Letter ↗AP
2025-12-22Labeling · Supplement 27 · standard — Letter ↗AP
2024-10-31REMS · Supplement 26 — Letter ↗AP
2023-12-15Labeling · Supplement 25 · standard — Label ↗AP
2021-09-10Labeling · Supplement 23 · standard — Label ↗AP
2021-03-04Labeling · Supplement 20 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 18 · standard — Letter ↗AP
2018-09-18REMS · Supplement 16 — Label ↗AP
2018-09-18Labeling · Supplement 17 · standard — Label ↗AP
2017-08-29Labeling · Supplement 15 · standard — Label ↗AP
2016-12-16Labeling · Supplement 14 · standard — Label ↗AP
2016-12-16Labeling · Supplement 12 · standard — Label ↗AP
2015-07-09Manufacturing (CMC) · Supplement 13 · standardAP
2015-01-20Manufacturing (CMC) · Supplement 11 · standardAP
2015-01-05Manufacturing (CMC) · Supplement 10 · standardAP
2013-08-13Manufacturing (CMC) · Supplement 9 · standardAP
2013-04-09Manufacturing (CMC) · Supplement 8 · standardAP
2010-05-07Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
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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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