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Details for New Drug Application (NDA): 200153

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NDA 200153 describes LIPTRUZET, 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. Additional details are available on the LIPTRUZET profile page.

The generic ingredient in LIPTRUZET is atorvastatin calcium; ezetimibe. There are sixty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the atorvastatin calcium; ezetimibe profile page.

Summary for NDA: 200153

Tradename:
LIPTRUZET
Applicant:
Merck Sharp Dohme
Ingredient:
atorvastatin calcium; ezetimibe
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 200153

Suppliers and Packaging for NDA: 200153

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL 200153 NDA Merck Sharp & Dohme Corp. 66582-320 66582-320-27 4 POUCH in 1 CARTON (66582-320-27) > 1 BLISTER PACK in 1 POUCH (66582-320-11) > 7 TABLET, FILM COATED in 1 BLISTER PACK
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL 200153 NDA Merck Sharp & Dohme Corp. 66582-320 66582-320-54 9 CARTON in 1 CARTON (66582-320-54) > 3 POUCH in 1 CARTON (66582-320-30) > 1 CASE in 1 POUCH (66582-320-10) > 1 BLISTER PACK in 1 CASE > 10 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 3, 2013TE:RLD:No
Patent:5,969,156*PEDPatent Expiration:Jan 8, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:RE42461*PEDPatent Expiration:Apr 25, 2017Product Flag?Substance Flag?Delist Request?
Regulatory Exclusivity Expiration:May 3, 2016
Regulatory Exclusivity Use:NEW COMBINATION

Expired Orange Book Patents for NDA: 200153

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-001May 3, 20135,686,104*PED► subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-004May 3, 20135,846,966*PED► subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-003May 3, 20135,686,104*PED► subscribe
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