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Deloitte
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Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204854

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NDA 204854 describes MEROPENEM, which is a drug marketed by Acs Dobfar, Acs Dobfar Spa, Amneal Pharms, Aurobindo Pharma Ltd, Daewoong Pharm Co, Gland Pharma Ltd, Hospira Inc, Sandoz, Savior Lifetec Corp, and B Braun Medical Inc, and is included in ten NDAs. It is available from eleven suppliers. Additional details are available on the MEROPENEM profile page.

The generic ingredient in MEROPENEM is meropenem. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the meropenem profile page.
Summary for 204854
Tradename:MEROPENEM
Applicant:Daewoong Pharm Co
Ingredient:meropenem
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 204854
Ingredient-typeCarbapenems
Suppliers and Packaging for NDA: 204854
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEROPENEM meropenem INJECTABLE;INJECTION 204854 ANDA Sagent Pharmaceuticals 25021-155 N 25021-155-15
MEROPENEM meropenem INJECTABLE;INJECTION 204854 ANDA Sagent Pharmaceuticals 25021-156 N 25021-156-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Dec 18, 2015TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:Dec 18, 2015TE:APRLD:No

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Harvard Business School
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