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Details for New Drug Application (NDA): 021549

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NDA 021549 describes EMEND, which is a drug marketed by Merck And Co Inc, Merck, and Msd Merck Co, and is included in three NDAs. It is available from three suppliers. There are three patents protecting this drug and three Paragraph IV challenges. Additional details are available on the EMEND profile page.

The generic ingredient in EMEND is aprepitant. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aprepitant profile page.

Summary for NDA: 021549

Tradename:
EMEND
Applicant:
Merck
Ingredient:
aprepitant
Patents:2
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021549

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMEND
aprepitant
CAPSULE;ORAL 021549 NDA Merck Sharp & Dohme Corp. 0006-0461 0006-0461-02 2 CAPSULE in 1 DOSE PACK (0006-0461-02)
EMEND
aprepitant
CAPSULE;ORAL 021549 NDA Merck Sharp & Dohme Corp. 0006-0461 0006-0461-06 1 BLISTER PACK in 1 CARTON (0006-0461-06) > 6 CAPSULE in 1 BLISTER PACK (0006-0461-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength80MG
Approval Date:Mar 26, 2003TE:ABRLD:No
Patent:6,096,742Patent Expiration:Jul 1, 2018Product Flag?Substance Flag?Delist Request?
Patent:6,096,742Patent Expiration:Jul 1, 2018Product Flag?YSubstance Flag?YDelist Request?
Patent:6,096,742Patent Expiration:Jul 1, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:FOR THE PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH CHEMOTHERAPY

Expired Orange Book Patents for NDA: 021549

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-001Mar 26, 20035,719,147► subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 20037,214,692► subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-003Jun 30, 20065,145,684► subscribe
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