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FDA NDA · NDA212728

NURTEC ODT

rimegepant sulfate

Sponsor: PFIZER

APPLICATION
NDA212728
TYPE
NDA
ORIGINAL APPROVAL
2020-02-27
LATEST ACTION
2026-05-08
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription

Products

NURTEC ODT · ReferencePrescription
RIMEGEPANT SULFATE EQ 75MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2026-05-08Labeling · Supplement 32 · standard — Label ↗AP
2026-03-16Labeling · Supplement 29 · standard — Letter ↗AP
2025-08-01Labeling · Supplement 28 · standard — Label ↗AP
2025-03-21Labeling · Supplement 26 · standard — Label ↗AP
2024-12-12Labeling · Supplement 25 · standard — Label ↗AP
2022-04-11Efficacy · Supplement 9 · standard — Letter ↗AP
2022-03-31Manufacturing (CMC) · Supplement 14 — Letter ↗AP
2021-12-08Labeling · Supplement 12 · standard — Letter ↗AP
2021-05-27Efficacy · Supplement 6 · standard — Label ↗AP
2020-08-18Labeling · Supplement 1 · standard — Label ↗AP
2020-02-27Type 1 - New Molecular Entity · Original · priority — Label ↗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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