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FDA NDA · NDA007959

TENSILON

Sponsor: PAI HOLDINGS PHARM

APPLICATION
NDA007959
TYPE
NDA
ORIGINAL APPROVAL
1951-05-03
LATEST ACTION
2003-02-26
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

TENSILON · ReferenceDiscontinued
EDROPHONIUM CHLORIDE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
TENSILON PRESERVATIVE FREE · ReferenceDiscontinued
EDROPHONIUM CHLORIDE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2003-02-26Labeling · Supplement 15 · standard — Letter ↗AP
2002-04-24Labeling · Supplement 13 · standard — Letter ↗AP
1997-10-01Manufacturing (CMC) · Supplement 14 · priorityAP
1993-08-09Manufacturing (CMC) · Supplement 12 · priorityAP
1986-01-03Manufacturing (CMC) · Supplement 8 · priorityAP
1985-03-07Manufacturing (CMC) · Supplement 7 · priorityAP
1983-04-05Labeling · Supplement 6AP
1951-05-03Type 1 - New Molecular Entity · Original · priorityAP
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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