Assyro AI

Orange Book product · Generic (ANDA)

VANCOCIN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE

Generic (ANDA)ANDA 062812DISCN STERISCIENCE

At a glance

Nov 17, 1987

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 17, 1987

    39 yr 2 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EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 062812

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.