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FDA NDA · NDA012003

AKINETON

Sponsor: ABBVIE

APPLICATION
NDA012003
TYPE
NDA
ORIGINAL APPROVAL
1959-09-08
LATEST ACTION
2002-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AKINETONDiscontinued
BIPERIDEN HYDROCHLORIDE 2MG · TABLET · ORAL

Approval history

2002-05-09Manufacturing (CMC) · Supplement 25 · standardAP
2002-02-04Labeling · Supplement 24 · standard — Letter ↗AP
2001-07-23Labeling · Supplement 19 — Letter ↗AP
2001-07-23Labeling · Supplement 21 — Letter ↗AP
2001-07-23Labeling · Supplement 18 — Letter ↗AP
2001-07-23Labeling · Supplement 20 — Letter ↗AP
2000-10-25Manufacturing (CMC) · Supplement 23 · standardAP
1987-12-17Manufacturing (CMC) · Supplement 22 · standardAP
1980-01-30Labeling · Supplement 16AP
1976-06-29Manufacturing (CMC) · Supplement 14 · standardAP
1976-01-14Manufacturing (CMC) · Supplement 13 · standardAP
1975-09-24Manufacturing (CMC) · Supplement 12 · standardAP
1975-05-12Manufacturing (CMC) · Supplement 11 · standardAP
1975-04-02Labeling · Supplement 10AP
1959-09-08Type 1 - New Molecular Entity · Original · standardAP
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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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