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Orange Book product · Generic (ANDA)

DOXEPIN HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE

Generic (ANDA)ANDA 212357TE ABRX AMNEAL

At a glance

Aug 16, 2023

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 16, 2023

    2 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DOXEPIN HYDROCHLORIDE

Strength

5%

Dosage form

CREAM

Route

TOPICAL

TE code

AB

Application

ANDA 212357

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DOXEPIN 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.