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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Citi
Express Scripts
Federal Trade Commission
Chubb
Fish and Richardson
US Army
AstraZeneca
Daiichi Sankyo

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050587

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NDA 050587 describes PRIMAXIN, which is a drug marketed by Merck and is included in three NDAs. It is available from one supplier. Additional details are available on the PRIMAXIN profile page.

The generic ingredient in PRIMAXIN is cilastatin sodium; imipenem. There are sixteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cilastatin sodium; imipenem profile page.
Summary for 050587
Tradename:PRIMAXIN
Applicant:Merck
Ingredient:cilastatin sodium; imipenem
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 050587
Ingredient-typeCarbapenems
Mechanism of ActionDipeptidase Inhibitors
Suppliers and Packaging for NDA: 050587
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRIMAXIN cilastatin sodium; imipenem POWDER;INTRAVENOUS 050587 NDA Merck Sharp & Dohme Corp. 0006-3516 N 0006-3516-59

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INTRAVENOUSStrengthEQ 250MG BASE/VIAL;250MG/VIAL
Approval Date:Nov 26, 1985TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 500MG BASE/VIAL;500MG/VIAL
Approval Date:Nov 26, 1985TE:APRLD:Yes

Expired US Patents for NDA 050587

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck PRIMAXIN cilastatin sodium; imipenem POWDER;INTRAVENOUS 050587-001 Nov 26, 1985 ➤ Sign Up ➤ Sign Up
Merck PRIMAXIN cilastatin sodium; imipenem POWDER;INTRAVENOUS 050587-002 Nov 26, 1985 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
UBS
Medtronic
Colorcon
McKinsey
Deloitte
Accenture
AstraZeneca
Cerilliant

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