Assyro AI

Orange Book product · Generic (ANDA)

BUTALBITAL, ASPIRIN AND CAFFEINE

ASPIRIN; BUTALBITAL; CAFFEINE

Generic (ANDA)ANDA 085441DISCN IVAX PHARMS

At a glance

Oct 31, 1984

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 31, 1984

    42 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ASPIRIN; BUTALBITAL; CAFFEINE

Strength

325MG;50MG;40MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 085441

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ASPIRIN; BUTALBITAL; CAFFEINE

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.