Assyro AI

Orange Book product · Generic (ANDA)

VANCOLED

VANCOMYCIN HYDROCHLORIDE

Generic (ANDA)ANDA 062682DISCN HIKMA

At a glance

Mar 30, 1988

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 30, 1988

    38 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

VANCOMYCIN HYDROCHLORIDE

Strength

EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 062682

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of VANCOMYCIN 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.