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Orange Book product · Generic (ANDA)

BUTALBITAL AND ACETAMINOPHEN

ACETAMINOPHEN; BUTALBITAL

Generic (ANDA)ANDA 205120DISCN ALVOGEN
View ACETAMINOPHEN; BUTALBITAL familyOpen on FDA Orange Book

At a glance

Oct 30, 2015

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 30, 2015

    10 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ACETAMINOPHEN; BUTALBITAL

Strength

325MG;50MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 205120

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ACETAMINOPHEN; BUTALBITAL

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.

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