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Last Updated: November 7, 2024

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. Three 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
Pharmacology for NDA: 050587
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 LLC 0006-3516 0006-3516-59 25 VIAL, SINGLE-DOSE in 1 TRAY (0006-3516-59) / 100 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INTRAVENOUSStrengthEQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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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