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Generated: November 21, 2018

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Details for New Drug Application (NDA): 021337

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NDA 021337 describes INVANZ, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from two suppliers. Additional details are available on the INVANZ profile page.

The generic ingredient in INVANZ is ertapenem sodium. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ertapenem sodium profile page.
Summary for 021337
Tradename:INVANZ
Applicant:Merck Sharp Dohme
Ingredient:ertapenem sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021337
Ingredient-typeCarbapenems
Suppliers and Packaging for NDA: 021337
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INVANZ ertapenem sodium INJECTABLE;INTRAMUSCULAR, IV (INFUSION) 021337 NDA Merck Sharp & Dohme Corp. 0006-3843 0006-3843-71 10 VIAL, SINGLE-DOSE in 1 TRAY (0006-3843-71) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
INVANZ ertapenem sodium INJECTABLE;INTRAMUSCULAR, IV (INFUSION) 021337 NDA Par Pharmaceutical Inc. 42023-221 42023-221-10 10 VIAL, SINGLE-DOSE in 1 TRAY (42023-221-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-221-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, IV (INFUSION)StrengthEQ 1GM BASE/VIAL
Approval Date:Nov 21, 2001TE:APRLD:Yes

Expired US Patents for NDA 021337

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme INVANZ ertapenem sodium INJECTABLE;INTRAMUSCULAR, IV (INFUSION) 021337-001 Nov 21, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme INVANZ ertapenem sodium INJECTABLE;INTRAMUSCULAR, IV (INFUSION) 021337-001 Nov 21, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme INVANZ ertapenem sodium INJECTABLE;INTRAMUSCULAR, IV (INFUSION) 021337-001 Nov 21, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme INVANZ ertapenem sodium INJECTABLE;INTRAMUSCULAR, IV (INFUSION) 021337-001 Nov 21, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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