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FDA ANDA · ANDA083242

AMEN

Sponsor: AMARIN PHARMS

APPLICATION
ANDA083242
TYPE
ANDA
ORIGINAL APPROVAL
1974-05-15
LATEST ACTION
1997-07-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMENDiscontinued
MEDROXYPROGESTERONE ACETATE 10MG · TABLET · ORAL

Approval history

1997-07-08Manufacturing (CMC) · Supplement 41AP
1997-05-05Manufacturing (CMC) · Supplement 40AP
1994-09-29Manufacturing (CMC) · Supplement 39AP
1994-09-28Labeling · Supplement 38AP
1994-02-03Labeling · Supplement 37AP
1993-01-29Manufacturing (CMC) · Supplement 36AP
1992-01-27Manufacturing (CMC) · Supplement 33AP
1991-06-25Labeling · Supplement 35AP
1991-03-28Manufacturing (CMC) · Supplement 34AP
1990-04-19Labeling · Supplement 32AP
1989-05-10Manufacturing (CMC) · Supplement 29AP
1989-02-10Manufacturing (CMC) · Supplement 31AP
1987-11-23Manufacturing (CMC) · Supplement 27AP
1986-08-08Manufacturing (CMC) · Supplement 20AP
1986-03-25Manufacturing (CMC) · Supplement 22AP
1986-03-25Manufacturing (CMC) · Supplement 23AP
1985-12-16Manufacturing (CMC) · Supplement 18AP
1985-12-16Manufacturing (CMC) · Supplement 16AP
1985-12-16Manufacturing (CMC) · Supplement 17AP
1984-06-22Manufacturing (CMC) · Supplement 14AP
1984-06-22Manufacturing (CMC) · Supplement 13AP
1974-05-15OriginalAP
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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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