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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 one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the INVANZ profile page.

The generic ingredient in INVANZ is ertapenem sodium. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ertapenem sodium profile page.

Summary for NDA: 021337

Tradename:
INVANZ
Applicant:
Merck Sharp Dohme
Ingredient:
ertapenem sodium
Patents:2
Therapeutic Class:Antibacterials
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 Merck Sharp & Dohme Corp. 0006-3845 0006-3845-71 10 VIAL, SINGLE-DOSE in 1 TRAY (0006-3845-71) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0006-3845-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, IV (INFUSION)StrengthEQ 1GM BASE/VIAL
Approval Date:Nov 21, 2001TE:RLD:Yes
Patent:5,478,820*PEDPatent Expiration:May 21, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:5,952,323*PEDPatent Expiration:Nov 15, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book 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)021337-001Nov 21, 20015,478,820*PED► subscribe
Merck Sharp Dohme
INVANZ
ertapenem sodium
INJECTABLE;INTRAMUSCULAR, IV (INFUSION)021337-001Nov 21, 20017,342,005*PED► subscribe
Merck Sharp Dohme
INVANZ
ertapenem sodium
INJECTABLE;INTRAMUSCULAR, IV (INFUSION)021337-001Nov 21, 20015,652,233*PED► subscribe
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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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