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FDA NDA · NDA020148

DIHYDROERGOTAMINE MESYLATE

Sponsor: BAUSCH

APPLICATION
NDA020148
TYPE
NDA
ORIGINAL APPROVAL
1997-12-08
LATEST ACTION
2022-05-09
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription

Products

MIGRANAL · ReferencePrescription
DIHYDROERGOTAMINE MESYLATE 0.5MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2022-05-09Labeling · Supplement 26 · standard — Letter ↗AP
2019-08-01Labeling · Supplement 25 · standard — Letter ↗AP
2014-08-14Manufacturing (CMC) · Supplement 24 · standardAP
2002-07-31Labeling · Supplement 8 · standard — Letter ↗AP
2002-07-31Labeling · Supplement 7 · standard — Label ↗AP
2001-12-04Manufacturing (CMC) · Supplement 15 · standardAP
2001-11-05Manufacturing (CMC) · Supplement 14 · standardAP
2001-10-31Manufacturing (CMC) · Supplement 13 · standardAP
2001-04-02Manufacturing (CMC) · Supplement 12 · standardAP
2000-11-30Manufacturing (CMC) · Supplement 11 · standardAP
2000-05-16Manufacturing (CMC) · Supplement 9 · standardAP
1999-01-19Manufacturing (CMC) · Supplement 6 · standardAP
1998-10-30Manufacturing (CMC) · Supplement 5 · standardAP
1998-06-26Manufacturing (CMC) · Supplement 1 · standardAP
1997-12-08Type 3 - New Dosage Form · Original · standard — Review ↗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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