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FDA NDA · NDA017962

BROMOCRIPTINE MESYLATE

Sponsor: ESJAY PHARMA

APPLICATION
NDA017962
TYPE
NDA
ORIGINAL APPROVAL
1978-06-28
LATEST ACTION
2026-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET, CAPSULE
MARKETING STATUS
Prescription

Products

PARLODEL · ReferencePrescription
BROMOCRIPTINE MESYLATE EQ 2.5MG BASE · TABLET · ORAL
PARLODEL · ReferencePrescription
BROMOCRIPTINE MESYLATE EQ 5MG BASE · CAPSULE · ORAL

Approval history

2026-06-30Labeling · Supplement 89 · standard — Letter ↗AP
2026-06-30Labeling · Supplement 80 · standard — Letter ↗AP
2021-07-12Labeling · Supplement 83 · standard — Label ↗AP
2019-12-13Labeling · Supplement 81 · standard — Letter ↗AP
2016-06-13Manufacturing (CMC) · Supplement 74 · priorityAP
2014-11-26Manufacturing (CMC) · Supplement 75 · priorityAP
2014-02-27Manufacturing (CMC) · Supplement 72 · priorityAP
2013-07-31Manufacturing (CMC) · Supplement 71 · priorityAP
2012-01-05Labeling · Supplement 65 · standard — Letter ↗AP
2012-01-05Labeling · Supplement 68 · unknown — Label ↗AP
2005-11-09Labeling · Supplement 63 · standard — Label ↗AP
2005-11-09Labeling · Supplement 64 · standard — Review ↗AP
2002-02-21Manufacturing (CMC) · Supplement 62 · priorityAP
2001-11-20Manufacturing (CMC) · Supplement 61 · priorityAP
2001-05-22Manufacturing (CMC) · Supplement 60 · priorityAP
2000-05-01Manufacturing (CMC) · Supplement 59 · priorityAP
1999-11-09Labeling · Supplement 53 · standardAP
1999-10-01Manufacturing (CMC) · Supplement 58 · priorityAP
1999-09-10Manufacturing (CMC) · Supplement 57 · priorityAP
1999-04-22Manufacturing (CMC) · Supplement 56 · priorityAP
1998-09-03Manufacturing (CMC) · Supplement 55 · priorityAP
1998-08-13Manufacturing (CMC) · Supplement 54 · priorityAP
1998-04-02Labeling · Supplement 52 · standardAP
1996-07-03Labeling · Supplement 51 · standardAP
1995-11-28Manufacturing (CMC) · Supplement 50 · priorityAP
1995-10-10Manufacturing (CMC) · Supplement 49 · priorityAP
1995-06-09Manufacturing (CMC) · Supplement 46 · priorityAP
1995-03-24Labeling · Supplement 48 · standardAP
1995-03-13Manufacturing (CMC) · Supplement 44 · priorityAP
1995-02-08Labeling · Supplement 47 · standardAP
1994-07-29Manufacturing (CMC) · Supplement 45 · priorityAP
1994-05-25Labeling · Supplement 42 · standardAP
1993-04-01Manufacturing (CMC) · Supplement 40 · priorityAP
1993-04-01Manufacturing (CMC) · Supplement 39 · priorityAP
1992-06-09Manufacturing (CMC) · Supplement 35 · priorityAP
1992-05-29Labeling · Supplement 36AP
1992-05-29Labeling · Supplement 38AP
1991-12-31Labeling · Supplement 27AP
1991-12-11Labeling · Supplement 37AP
1990-10-22Manufacturing (CMC) · Supplement 34 · priorityAP
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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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