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FDA NDA · NDA205525

DRONABINOL

Sponsor: WELLHOUSE PHARMA

APPLICATION
NDA205525
TYPE
NDA
ORIGINAL APPROVAL
2016-07-01
LATEST ACTION
2024-05-17
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

SYNDROS · ReferenceDiscontinued
DRONABINOL 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2024-05-17Labeling · Supplement 13 · standard — Label ↗AP
2022-09-21Labeling · Supplement 11 · standard — Letter ↗AP
2021-03-22Labeling · Supplement 9 · standard — Letter ↗AP
2018-09-14Labeling · Supplement 7 · standard — Label ↗AP
2018-04-12Labeling · Supplement 5 · standardAP
2017-05-25Labeling · Supplement 3 · standard — Letter ↗AP
2016-12-08Manufacturing (CMC) · Supplement 1AP
2016-07-01Type 3 - New Dosage Form · 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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