Assyro AI

Orange Book product · Generic (ANDA)

RIFAMPIN AND ISONIAZID

ISONIAZID; RIFAMPIN

Generic (ANDA)ANDA 065221DISCN HIKMA INTL PHARMS

At a glance

Jul 29, 2005

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 29, 2005

    21 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ISONIAZID; RIFAMPIN

Strength

150MG;300MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 065221

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ISONIAZID; RIFAMPIN

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.