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Orange Book product · Generic (ANDA)

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

Generic (ANDA)ANDA 202934TE ABRX ACTAVIS ELIZABETH

At a glance

Oct 10, 2017

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 10, 2017

    8 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

Strength

20MG;10MG

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

ANDA 202934

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

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.