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Orange Book product · Generic (ANDA)

VANCOMYCIN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE

Generic (ANDA)ANDA 214913TE AARX ALKEM LABS LTD
View VANCOMYCIN HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Nov 14, 2022

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 14, 2022

    3 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

VANCOMYCIN HYDROCHLORIDE

Strength

EQ 25MG BASE/ML

Dosage form

FOR SOLUTION

Route

ORAL

TE code

AA

Application

ANDA 214913

Product number

001

Marketing status

RX

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.

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