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NUTRESTORE

NDA

L-GLUTAMINE | N021667 | EMMAUS MEDICAL INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain6 active DMFs1 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

AJINOMOTO DO BRASIL INDUSTRIA E COMERCIO DE ALIMENTOS LTDAL-GLUTAMINE

DMF 196732006

FUJIFILM IRVINE SCIENTIFIC INCL-GLUTAMINE (200MM)- LIQUID

DMF 279512014

SS PHARMA LLCL-GLUTAMINE USP

DMF 360822021

BIOPHORE INDIA PHARMACEUTICALS PVT LTDL-GLUTAMINE

DMF 376952022

HOSTER LABS PRIVATE LTDL-GLUTAMINE

DMF 388182023

METROCHEM API PRIVATE LTDL-GLUTAMINE USP

DMF 389922023

TANABE SEIYAKU CO LTDInactiveL-GLUTAMINE

DMF 18331971

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 1, 2021	SUPPL -7	View Letter (PDF)
Mar 16, 2011	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5GM/PACKET

RLD

0 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Jun 10, 2004

No patent or exclusivity listings for this strength.