APPLICATION
ANDA074631
TYPE
ANDA
ORIGINAL APPROVAL
1998-01-13
LATEST ACTION
2022-11-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BROMOCRIPTINE MESYLATEPrescription
BROMOCRIPTINE MESYLATE EQ 2.5MG BASE · TABLET · ORAL
Approval history
2022-11-08Labeling · Supplement 13 · standardAP
2021-01-07Labeling · Supplement 10 · standardAP
2015-02-18Labeling · Supplement 9 · standardAP
2002-01-28Manufacturing (CMC) · Supplement 5AP
2002-01-28Manufacturing (CMC) · Supplement 3AP
2002-01-28Manufacturing (CMC) · Supplement 1AP
2002-01-28Labeling · Supplement 4AP
2002-01-28Manufacturing (CMC) · Supplement 2AP
1998-01-13OriginalAP
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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