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Orange Book product · Generic (ANDA)

GLYCOPYRRONIUM TOSYLATE

GLYCOPYRRONIUM TOSYLATE

Generic (ANDA)ANDA 214448DISCN PADAGIS US

At a glance

Apr 03, 2026

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 03, 2026

    3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GLYCOPYRRONIUM TOSYLATE

Strength

EQ 2.4% BASE

Dosage form

CLOTH

Route

TOPICAL

TE code

Not listed

Application

ANDA 214448

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of GLYCOPYRRONIUM TOSYLATE

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.