Assyro AI

Orange Book product · Brand (NDA)

ENDARI

L-GLUTAMINE

Brand (NDA)NDA 208587TE AARX EMMAUS MEDCL

At a glance

Jul 07, 2017

Approved

Brand (NDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 07, 2017

    9 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

L-GLUTAMINE

Strength

5GM/PACKET

Dosage form

FOR SOLUTION

Route

ORAL

TE code

AA

Application

NDA 208587

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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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