Assyro AI

Orange Book product · Generic (ANDA)

ISONIAZID

ISONIAZID

Generic (ANDA)ANDA 088235TE AARX CMP PHARMA INC

At a glance

Nov 10, 1983

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 10, 1983

    43 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ISONIAZID

Strength

50MG/5ML

Dosage form

SYRUP

Route

ORAL

TE code

AA

Application

ANDA 088235

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of ISONIAZID

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.