Assyro AI

Orange Book product · Generic (ANDA)

CLEMASTINE FUMARATE

CLEMASTINE FUMARATE

Generic (ANDA)ANDA 073283RX GENUS

At a glance

Jan 31, 1992

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 31, 1992

    34 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CLEMASTINE FUMARATE

Strength

2.68MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 073283

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.

Agent CTA Background

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