Assyro AI

Orange Book product · Brand (NDA)

BLOXIVERZ

NEOSTIGMINE METHYLSULFATE

Brand (NDA)NDA 204078DISCN EXELA PHARMA

At a glance

May 31, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 31, 2013

    13 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NEOSTIGMINE METHYLSULFATE

Strength

5MG/10ML (0.5MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 204078

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.