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Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062756

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NDA 062756 describes PRIMAXIN, which is a drug marketed by Merck and is included in three NDAs. It is available from two suppliers. 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 NDA: 062756

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 062756

Ingredient-typeCarbapenems
Mechanism of ActionDipeptidase Inhibitors

Suppliers and Packaging for NDA: 062756

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRIMAXIN
cilastatin sodium; imipenem
INJECTABLE;INJECTION 062756 ANDA Merck Sharp & Dohme Corp. 0006-3551 0006-3551-58 25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0006-3551-58) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
PRIMAXIN
cilastatin sodium; imipenem
INJECTABLE;INJECTION 062756 ANDA Merck Sharp & Dohme Corp. 0006-3552 0006-3552-59 25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0006-3552-59) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/VIAL;250MG/VIAL
Approval Date:Jan 8, 1987TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL;500MG/VIAL
Approval Date:Jan 8, 1987TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Covington
Novartis
Farmers Insurance
US Army
Deloitte
Moodys
Boehringer Ingelheim
Cipla
McKesson
AstraZeneca

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