Assyro AI

Orange Book product · Generic (ANDA)

CLEMASTINE FUMARATE

CLEMASTINE FUMARATE

Generic (ANDA)ANDA 074863DISCN WOCKHARDT BIO AG

At a glance

Mar 13, 1998

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 13, 1998

    28 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CLEMASTINE FUMARATE

Strength

EQ 0.5MG BASE/5ML

Dosage form

SYRUP

Route

ORAL

TE code

Not listed

Application

ANDA 074863

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

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.