Assyro AI

Orange Book product · Generic (ANDA)

DILTIAZEM HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE

Generic (ANDA)ANDA 074845DISCN BIOVAIL

At a glance

Sep 15, 1999

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 15, 1999

    27 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DILTIAZEM HYDROCHLORIDE

Strength

60MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 074845

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DILTIAZEM 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.