← FDA DRUG APPROVALS

FDA NDA · NDA210875

KYNMOBI

Sponsor: SUMITOMO PHARMA AM

APPLICATION
NDA210875
TYPE
NDA
ORIGINAL APPROVAL
2020-05-21
LATEST ACTION
2022-09-22
ROUTE
SUBLINGUAL
DOSAGE FORM
FILM
MARKETING STATUS
Discontinued

Products

KYNMOBI · ReferenceDiscontinued
APOMORPHINE HYDROCHLORIDE 30MG · FILM · SUBLINGUAL
KYNMOBI · ReferenceDiscontinued
APOMORPHINE HYDROCHLORIDE 20MG · FILM · SUBLINGUAL
KYNMOBI · ReferenceDiscontinued
APOMORPHINE HYDROCHLORIDE 10MG · FILM · SUBLINGUAL
KYNMOBI · ReferenceDiscontinued
APOMORPHINE HYDROCHLORIDE 25MG · FILM · SUBLINGUAL
KYNMOBI · ReferenceDiscontinued
APOMORPHINE HYDROCHLORIDE 15MG · FILM · SUBLINGUAL

Approval history

2022-09-22Efficacy · Supplement 6 · standard — Label ↗AP
2022-05-05Labeling · Supplement 7 · standard — Letter ↗AP
2020-05-21Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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