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Orange Book product · Generic (ANDA)

NIZATIDINE

NIZATIDINE

Generic (ANDA)ANDA 077314TE ABRX DR REDDYS LABS LTD
View NIZATIDINE familyOpen on FDA Orange Book

At a glance

Sep 15, 2005

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 15, 2005

    21 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NIZATIDINE

Strength

150MG

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

ANDA 077314

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of NIZATIDINE

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

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