Assyro AI

Orange Book product · Generic (ANDA)

MORPHINE SULFATE

MORPHINE SULFATE

Generic (ANDA)ANDA 076438TE ABRX SPECGX LLC

At a glance

Jul 03, 2003

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 03, 2003

    23 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MORPHINE SULFATE

Strength

100MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

AB

Application

ANDA 076438

Product number

001

Marketing status

RX

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.