Assyro AI

Orange Book product · Generic (ANDA)

CLONIDINE HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE

Generic (ANDA)ANDA 200300TE APRX HIKMA FARMACEUTICA

At a glance

Jan 26, 2011

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 26, 2011

    15 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CLONIDINE HYDROCHLORIDE

Strength

5MG/10ML (0.5MG/ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 200300

Product number

002

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of CLONIDINE HYDROCHLORIDE

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.