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Orange Book product · Generic (ANDA)

LANSOPRAZOLE

LANSOPRAZOLE

Generic (ANDA)ANDA 208671DISCN MACLEODS PHARMS LTD

At a glance

Nov 04, 2024

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 04, 2024

    1 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LANSOPRAZOLE

Strength

15MG

Dosage form

CAPSULE, DELAYED REL PELLETS

Route

ORAL

TE code

Not listed

Application

ANDA 208671

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of LANSOPRAZOLE

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.