Assyro AI

Orange Book product · Generic (ANDA)

SAXAGLIPTIN

SAXAGLIPTIN HYDROCHLORIDE

Generic (ANDA)ANDA 205994TE ABRX GLENMARK PHARMS LTD

At a glance

Jul 31, 2023

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 31, 2023

    2 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SAXAGLIPTIN HYDROCHLORIDE

Strength

EQ 2.5MG BASE

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 205994

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of SAXAGLIPTIN 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.