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FDA NDA · NDA022256

SAVELLA

milnacipran hydrochloride

Sponsor: ABBVIE

APPLICATION
NDA022256
TYPE
NDA
ORIGINAL APPROVAL
2009-01-14
LATEST ACTION
2025-09-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SAVELLA · ReferencePrescription
MILNACIPRAN HYDROCHLORIDE 100MG · TABLET · ORAL
SAVELLA · ReferencePrescription
MILNACIPRAN HYDROCHLORIDE 25MG · TABLET · ORAL
SAVELLA · ReferencePrescription
MILNACIPRAN HYDROCHLORIDE 50MG · TABLET · ORAL
SAVELLA · ReferencePrescription
MILNACIPRAN HYDROCHLORIDE 12.5MG · TABLET · ORAL

Approval history

2025-09-10Labeling · Supplement 31 · standard — Letter ↗AP
2024-05-22Labeling · Supplement 29 · standard — Letter ↗AP
2023-08-18Labeling · Supplement 28 · standard — Label ↗AP
2022-12-23Labeling · Supplement 24 · standard — Letter ↗AP
2021-09-20Labeling · Supplement 25 · standard — Label ↗AP
2017-12-19Labeling · Supplement 23 · standard — Label ↗AP
2016-12-30Labeling · Supplement 22 · standard — Label ↗AP
2016-09-06Labeling · Supplement 21 · standard — Letter ↗AP
2015-06-17Manufacturing (CMC) · Supplement 20 · standardAP
2015-05-21Manufacturing (CMC) · Supplement 18 · standardAP
2015-01-29Labeling · Supplement 19 · standard — Label ↗AP
2013-11-25Manufacturing (CMC) · Supplement 17 · standardAP
2013-10-30Labeling · Supplement 15 · standard — Label ↗AP
2013-10-30Labeling · Supplement 14 · standard — Label ↗AP
2013-06-25Manufacturing (CMC) · Supplement 16 · standard — Label ↗AP
2012-12-06Labeling · Supplement 13 · standard — Label ↗AP
2012-10-30Labeling · Supplement 12 · standard — Letter ↗AP
2011-11-08Labeling · Supplement 11 · standard — Label ↗AP
2011-04-26REMS · Supplement 10 — Review ↗AP
2010-06-01Manufacturing (CMC) · Supplement 5AP
2010-05-17Labeling · Supplement 6 · unknown — Letter ↗AP
2010-02-02REMS · Supplement 4 · unknown — Letter ↗AP
2010-02-01Labeling · Supplement 2 · standard — Letter ↗AP
2009-04-16Manufacturing (CMC) · Supplement 1 — Label ↗AP
2009-01-14Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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