Assyro AI

Orange Book product · Generic (ANDA)

MORPHINE SULFATE

MORPHINE SULFATE

Generic (ANDA)ANDA 208809DISCN HIKMA

At a glance

Jul 06, 2017

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 06, 2017

    9 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MORPHINE SULFATE

Strength

100MG/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

ANDA 208809

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of MORPHINE SULFATE

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.