Assyro AI

Orange Book product · Brand (NDA)

ZONALON

DOXEPIN HYDROCHLORIDE

Brand (NDA)NDA 020126TE ABRX MYLAN
View DOXEPIN HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Apr 01, 1994

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 01, 1994

    32 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DOXEPIN HYDROCHLORIDE

Strength

5%

Dosage form

CREAM

Route

TOPICAL

TE code

AB

Application

NDA 020126

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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

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