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FDA NDA · NDA019677

ENLON-PLUS

Sponsor: PHARMOBEDIENT

APPLICATION
NDA019677
TYPE
NDA
ORIGINAL APPROVAL
1991-11-06
LATEST ACTION
2025-10-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ENLON-PLUSDiscontinued
ATROPINE SULFATE 0.14MG/ML, EDROPHONIUM CHLORIDE 10MG/ML · INJECTABLE · INJECTION

Approval history

2025-10-28Labeling · Supplement 11 · standard — Label ↗AP
2009-04-01Manufacturing (CMC) · Supplement 6 · standard — Label ↗AP
2005-12-06Labeling · Supplement 5 · standard — Letter ↗AP
2002-04-18Manufacturing (CMC) · Supplement 4 · standardAP
2000-12-26Manufacturing (CMC) · Supplement 3 · standardAP
1994-03-11Manufacturing (CMC) · Supplement 2 · standardAP
1992-03-20Manufacturing (CMC) · Supplement 1 · standardAP
1991-11-06Type 4 - New Combination · 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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