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Generated: December 16, 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 062756

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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