Assyro AI

Orange Book product · Brand (NDA)

MORPHINE SULFATE

MORPHINE SULFATE

Brand (NDA)NDA 022195TE AARX HIKMA

At a glance

Mar 17, 2008

Approved

Brand (NDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 17, 2008

    18 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MORPHINE SULFATE

Strength

10MG/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

AA

Application

NDA 022195

Product number

001

Marketing status

RX

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.