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Generated: November 15, 2018

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Details for New Drug Application (NDA): 208313

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NDA 208313 describes INFUGEM, which is a drug marketed by Sun Pharm Inds Ltd and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the INFUGEM profile page.

The generic ingredient in INFUGEM is gemcitabine hydrochloride. There are twenty-nine drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
Summary for 208313
Tradename:INFUGEM
Applicant:Sun Pharm Inds Ltd
Ingredient:gemcitabine hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 208313
Suppliers and Packaging for NDA: 208313
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INFUGEM gemcitabine hydrochloride SOLUTION;INTRAVENOUS 208313 NDA Sun Pharmaceutical Industries, Inc. 62756-008 62756-008-60 1 POUCH in 1 CARTON (62756-008-60) > 1 BAG in 1 POUCH > 130 mL in 1 BAG
INFUGEM gemcitabine hydrochloride SOLUTION;INTRAVENOUS 208313 NDA Sun Pharmaceutical Industries, Inc. 62756-073 62756-073-60 1 POUCH in 1 CARTON (62756-073-60) > 1 BAG in 1 POUCH > 120 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 1200MG BASE/120ML (EQ 10MG BASE/ML)
Approval Date:Jul 16, 2018TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jul 1, 2033Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 1300MG BASE/130ML (EQ 10MG BASE/ML)
Approval Date:Jul 16, 2018TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jul 1, 2033Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 1400MG BASE/140ML (EQ 10MG BASE/ML)
Approval Date:Jul 16, 2018TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jul 1, 2033Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Express Scripts
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Merck
McKesson
Medtronic
Queensland Health
Moodys

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