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ELIGLUSTAT TARTRATE

ANDA

ELIGLUSTAT TARTRATE | A212463 | AIZANT DRUG RESEARCH SOLUTIONS PVT LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: CERDELGA(TE code: AB)

API Supply Chain7 active DMFs

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

DR REDDYS LABORATORIES LTDELIGLUSTAT TARTRATE

DMF 314752017

BIOPHORE INDIA PHARMACEUTICALS PVT LTDELIGLUSTAT TARTRATE

DMF 325722018

MAITHRI LABORATORIES PRIVATE LTDELIGLUSTAT TARTRATE (PREMIX)

DMF 326122018

MAITHRI LABORATORIES PRIVATE LTDELIGLUSTAT TARTRATE

DMF 326532018

APOTEX INCELIGLUSTAT TARTRATE (1:0.5)

DMF 327242018

BIOPHORE INDIA PHARMACEUTICALS PVT LTDELIGLUSTAT TARTRATE PREMIX

DMF 328602018

HETERO DRUGS LTDELIGLUSTAT TARTRATE

DMF 416192025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 8, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 84MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Sep 8, 2021

No patent or exclusivity listings for this strength.