Assyro AI

Orange Book product · Brand (NDA)

ENLON-PLUS

ATROPINE SULFATE; EDROPHONIUM CHLORIDE

Brand (NDA)NDA 019678DISCN PHARMOBEDIENT
View ATROPINE SULFATE; EDROPHONIUM CHLORIDE familyOpen on FDA Orange Book

At a glance

Nov 06, 1991

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 06, 1991

    35 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ATROPINE SULFATE; EDROPHONIUM CHLORIDE

Strength

0.14MG/ML;10MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 019678

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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