Assyro AI

Orange Book product · Generic (ANDA)

CLEMASTINE FUMARATE

CLEMASTINE FUMARATE

Generic (ANDA)ANDA 073399TE AARX GENUS
View CLEMASTINE FUMARATE familyOpen on FDA Orange Book

At a glance

Jun 30, 1994

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 30, 1994

    32 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CLEMASTINE FUMARATE

Strength

EQ 0.5MG BASE/5ML

Dosage form

SYRUP

Route

ORAL

TE code

AA

Application

ANDA 073399

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of CLEMASTINE FUMARATE

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.

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