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FDA NDA · NDA012418

AKINETON

Sponsor: ABBVIE

APPLICATION
NDA012418
TYPE
NDA
ORIGINAL APPROVAL
1961-04-20
LATEST ACTION
2001-07-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

AKINETONDiscontinued
BIPERIDEN LACTATE 5MG/ML · INJECTABLE · INJECTION

Approval history

2001-07-23Labeling · Supplement 9 · standard — Letter ↗AP
2001-07-23Labeling · Supplement 7 · standard — Letter ↗AP
2001-07-23Labeling · Supplement 8 · standard — Letter ↗AP
2001-07-23Labeling · Supplement 6 · standard — Letter ↗AP
1979-10-18Manufacturing (CMC) · Supplement 5 · standardAP
1976-01-30Manufacturing (CMC) · Supplement 4 · standardAP
1961-04-20Type 2 - New Active Ingredient · Original · standardAP
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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