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FDA ANDA · ANDA087693

ERGOMAR SUBLINGUAL

ergotamine tartrate

Sponsor: PANGEA

APPLICATION
ANDA087693
TYPE
ANDA
ORIGINAL APPROVAL
1992-09-25
LATEST ACTION
2009-12-07
ROUTE
ORAL, SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ERGOMAR · ReferencePrescription
ERGOTAMINE TARTRATE 2MG · TABLET · SUBLINGUAL

Approval history

2009-12-07Labeling · Supplement 29AP
2003-10-20Labeling · Supplement 23AP
1995-06-30Manufacturing (CMC) · Supplement 16AP
1995-06-30Labeling · Supplement 17AP
1992-09-25OriginalAP
1992-06-30Manufacturing (CMC) · Supplement 11AP
1990-09-14Manufacturing (CMC) · Supplement 15AP
1989-06-30Labeling · Supplement 12AP
1989-06-30Manufacturing (CMC) · Supplement 10AP
1988-10-14Bioequivalence · Supplement 13AP
1987-07-09Manufacturing (CMC) · Supplement 9AP
1987-06-09Manufacturing (CMC) · Supplement 7AP
1985-04-18Manufacturing (CMC) · Supplement 5AP
1985-04-18Manufacturing (CMC) · Supplement 6AP
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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