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Orange Book product · Generic (ANDA)

PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE

Generic (ANDA)ANDA 040515DISCN AM REGENT
View PROMETHAZINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Mar 19, 2003

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 19, 2003

    23 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PROMETHAZINE HYDROCHLORIDE

Strength

25MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 040515

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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