Assyro AI

Orange Book product · Generic (ANDA)

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Generic (ANDA)ANDA 071443RX MYLAN

At a glance

Nov 10, 1988

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 10, 1988

    38 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Strength

10MG;2MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 071443

Product number

002

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

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.