← FDA DRUG APPROVALS

FDA NDA · NDA021829

NEUPRO

rotigotine

Sponsor: UCB INC

APPLICATION
NDA021829
TYPE
NDA
ORIGINAL APPROVAL
2007-05-09
LATEST ACTION
2021-07-12
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

NEUPRO · ReferencePrescription
ROTIGOTINE 1MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
NEUPRO · ReferencePrescription
ROTIGOTINE 4MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
NEUPRO · ReferencePrescription
ROTIGOTINE 3MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
NEUPRO · ReferencePrescription
ROTIGOTINE 6MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
NEUPRO · ReferencePrescription
ROTIGOTINE 2MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL
NEUPRO · ReferencePrescription
ROTIGOTINE 8MG/24HR · FILM, EXTENDED RELEASE · TRANSDERMAL

Approval history

2021-07-12Labeling · Supplement 21 · standard — Letter ↗AP
2021-07-12Labeling · Supplement 22 · standard — Letter ↗AP
2020-04-24Labeling · Supplement 17 · standard — Label ↗AP
2020-04-03Labeling · Supplement 19 · 901 required — Letter ↗AP
2019-01-18Labeling · Supplement 16 · standard — Label ↗AP
2018-11-29Labeling · Supplement 15 · standard — Label ↗AP
2017-01-30Manufacturing (CMC) · Supplement 11 · standardAP
2016-06-03Manufacturing (CMC) · Supplement 10 · standardAP
2015-09-10Manufacturing (CMC) · Supplement 9 · standardAP
2015-02-26Labeling · Supplement 7 · standard — Label ↗AP
2012-04-02Efficacy · Supplement 2 · standard — Label ↗AP
2012-04-02Efficacy · Supplement 1 · standard — Review ↗AP
2007-05-09Type 1 - New Molecular Entity · Original · standard — Label ↗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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