← FDA DRUG APPROVALS

FDA NDA · NDA203340

NYMALIZE

nimodipine

Sponsor: AZURITY

APPLICATION
NDA203340
TYPE
NDA
ORIGINAL APPROVAL
2013-05-10
LATEST ACTION
2024-08-28
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Prescription

Products

NYMALIZE · ReferenceDiscontinued
NIMODIPINE 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL
NYMALIZE · ReferencePrescription
NIMODIPINE 6MG/ML · SOLUTION · ORAL

Approval history

2024-08-28Manufacturing (CMC) · Supplement 19 — Letter ↗AP
2020-12-18Manufacturing (CMC) · Supplement 13 · standard — Label ↗AP
2020-04-09Manufacturing (CMC) · Supplement 11 — Label ↗AP
2019-12-28Labeling · Supplement 12 · standard — Label ↗AP
2016-03-02Manufacturing (CMC) · Supplement 1 · priorityAP
2015-08-26Manufacturing (CMC) · Supplement 3 · priorityAP
2015-08-07Manufacturing (CMC) · Supplement 2 · priorityAP
2013-05-10Type 3 - New Dosage Form · Original · priority — Review ↗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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