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ARGATROBAN IN SODIUM CHLORIDE

ANDA

ARGATROBAN | A205570 | GLAND PHARMA LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ARGATROBAN IN SODIUM CHLORIDE(TE code: AP)

API Supply Chain10 active DMFs1 inactive

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

CHEMWERTH INCARGATROBAN HYDRATE (NON-STERILE BULK) DRUG SUBSTANCE

DMF 207092007

CURIA ITALY SRLARGATROBAN

DMF 207602007

LUNDBECK PHARMACEUTICALS ITALY SPAARGATROBAN

DMF 213042008

GLAND PHARMA LTDARGATROBAN MONOHYDRATE USP

DMF 254002011

EMCURE PHARMACEUTICALS LTDARGATROBAN USP

DMF 257652012

ALP PHARM BEIJING CO LTDARGATROBAN HYDRATE

DMF 258932012

GLAND PHARMA LTDARGATROBAN MONOHYDRATE (PROCESS-II)

DMF 280302014

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDARGATROBAN

DMF 354912020

CURIA ITALY SRLARGATROBAN MONOHYDRATE

DMF 402272024

SUZHOU RYWAY BIOTECH CO LTDARGATROBAN

DMF 424262025

SCINOPHARM TAIWAN LTDInactiveARGATROBAN

DMF 229352009

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 5, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 125MG/125ML (1MG/ML)

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: May 22, 2017

No patent or exclusivity listings for this strength.