Assyro AI

Orange Book product · Generic (ANDA)

BUTORPHANOL TARTRATE

BUTORPHANOL TARTRATE

Generic (ANDA)ANDA 075499TE ABRX APOTEX

At a glance

Dec 04, 2002

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 04, 2002

    23 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

BUTORPHANOL TARTRATE

Strength

1MG/SPRAY

Dosage form

SPRAY, METERED

Route

NASAL

TE code

AB

Application

ANDA 075499

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of BUTORPHANOL TARTRATE

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.