Assyro AI

Orange Book product · Generic (ANDA)

DILTIAZEM HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE

Generic (ANDA)ANDA 074943TE AB2RX APOTEX

At a glance

Aug 06, 1998

Approved

Generic (ANDA)

Application

AB2

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 06, 1998

    28 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DILTIAZEM HYDROCHLORIDE

Strength

240MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

AB2

Application

ANDA 074943

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.