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Orange Book product · Generic (ANDA)

NEOSTIGMINE METHYLSULFATE

NEOSTIGMINE METHYLSULFATE

Generic (ANDA)ANDA 207042TE APRX HIKMA
View NEOSTIGMINE METHYLSULFATE familyOpen on FDA Orange Book

At a glance

Dec 28, 2015

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 28, 2015

    10 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NEOSTIGMINE METHYLSULFATE

Strength

5MG/10ML (0.5MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP

Application

ANDA 207042

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of NEOSTIGMINE METHYLSULFATE

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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