Assyro AI

Orange Book product · Generic (ANDA)

DICYCLOMINE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE

Generic (ANDA)ANDA 089361DISCN PIONEER PHARMS

At a glance

Jan 10, 1989

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 10, 1989

    38 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

DICYCLOMINE HYDROCHLORIDE

Strength

10MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 089361

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DICYCLOMINE HYDROCHLORIDE

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.