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Generated: March 22, 2019

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Details for New Drug Application (NDA): 205375

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NDA 205375 describes CLOFARABINE, which is a drug marketed by Abon Pharms Llc, Amneal Pharms Co, Dr Reddys Labs Ltd, Gland Pharma Ltd, Ingenus Pharms Llc, Msn Labs Pvt Ltd, and Mylan Labs Ltd, and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the CLOFARABINE profile page.

The generic ingredient in CLOFARABINE is clofarabine. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the clofarabine profile page.
Summary for 205375
Applicant:Dr Reddys Labs Ltd
Pharmacology for NDA: 205375
Suppliers and Packaging for NDA: 205375
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOFARABINE clofarabine SOLUTION;INTRAVENOUS 205375 ANDA Dr.Reddy's Laboratories Inc 43598-309 43598-309-20 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-309-20) > 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength20MG/20ML (1MG/ML)
Approval Date:Nov 6, 2017TE:APRLD:No

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