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Orange Book product · Generic (ANDA)

VANCOMYCIN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE

Generic (ANDA)ANDA 091532RX SAMSON MEDCL
View VANCOMYCIN HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Jan 06, 2016

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 06, 2016

    10 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

VANCOMYCIN HYDROCHLORIDE

Strength

EQ 100GM BASE

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

ANDA 091532

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.

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