← FDA DRUG APPROVALS

FDA NDA · NDA020866

CYCLOSET

bromocriptine mesylate

Sponsor: VEROSCIENCE

APPLICATION
NDA020866
TYPE
NDA
ORIGINAL APPROVAL
2009-05-05
LATEST ACTION
2020-08-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CYCLOSET · ReferencePrescription
BROMOCRIPTINE MESYLATE EQ 0.8MG BASE · TABLET · ORAL

Approval history

2020-08-17Labeling · Supplement 12 · standard — Letter ↗AP
2020-04-03Labeling · Supplement 13 · 901 required — Letter ↗AP
2017-02-06Labeling · Supplement 7 · standard — Label ↗AP
2017-02-06Labeling · Supplement 6 · standard — Label ↗AP
2016-02-02Labeling · Supplement 9 · standard — Label ↗AP
2015-10-20Labeling · Supplement 8 · standard — Label ↗AP
2013-06-12Manufacturing (CMC) · Supplement 3 · standardAP
2013-03-14Manufacturing (CMC) · Supplement 5 · standardAP
2011-03-24Labeling · Supplement 2 · unknown — Letter ↗AP
2009-05-05Type 3 - New Dosage Form · Original · standard — Review ↗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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