Assyro AI

Orange Book product · Generic (ANDA)

METHYLNALTREXONE BROMIDE

METHYLNALTREXONE BROMIDE

Generic (ANDA)ANDA 208112DISCN ACTAVIS LLC

At a glance

Aug 26, 2024

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 26, 2024

    1 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

METHYLNALTREXONE BROMIDE

Strength

8MG/0.4ML (8MG/0.4ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

ANDA 208112

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of METHYLNALTREXONE BROMIDE

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.