Assyro AI

Orange Book product · Generic (ANDA)

HEPATASOL 8%

AMINO ACIDS

Generic (ANDA)ANDA 020360DISCN BAXTER HLTHCARE

At a glance

Apr 04, 1996

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 04, 1996

    30 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

AMINO ACIDS

Strength

8% (8GM/100ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 020360

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of AMINO ACIDS

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.