Assyro AI

Orange Book product · Generic (ANDA)

PROMETHAZINE PLAIN

PROMETHAZINE HYDROCHLORIDE

Generic (ANDA)ANDA 087953TE AARX PHARMOBEDIENT
View PROMETHAZINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Nov 15, 1982

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 15, 1982

    44 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PROMETHAZINE HYDROCHLORIDE

Strength

6.25MG/5ML

Dosage form

SYRUP

Route

ORAL

TE code

AA

Application

ANDA 087953

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of PROMETHAZINE 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

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