APPLICATION
ANDA077226
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-04
LATEST ACTION
2020-08-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
BROMOCRIPTINE MESYLATEPrescription
BROMOCRIPTINE MESYLATE EQ 5MG BASE · CAPSULE · ORAL
Approval history
2020-08-21Labeling · Supplement 11 · standardAP
2015-02-13Labeling · Supplement 8 · standardAP
2006-08-15Labeling · Supplement 1AP
2005-04-04OriginalAP
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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