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ETHACRYNATE SODIUM

ANDA

ETHACRYNATE SODIUM | A205473 | PH HEALTH LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: EDECRIN(TE code: AP)

API Supply Chain2 active DMFs1 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CHEMWERTH INCETHACRYNATE SODIUM NON-STERILE, BULK DRUG

DMF 263382013

BIOPHORE INDIA PHARMACEUTICALS PVT LTDETHACRYNATE SODIUM

DMF 308132016

SAI LIFE SCIENCES LTDInactiveETHACRYNATE SODIUM

DMF 316002017

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 3, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 50MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jul 29, 2015

No patent or exclusivity listings for this strength.