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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 021549


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

The generic ingredient in EMEND is fosaprepitant dimeglumine. There are eleven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.
Summary for 021549
Tradename:EMEND
Applicant:Merck
Ingredient:aprepitant
Patents:1
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 LLC 0006-0461 0006-0461-02 2 CAPSULE in 1 DOSE PACK (0006-0461-02)
EMEND aprepitant CAPSULE;ORAL 021549 NDA Merck Sharp & Dohme LLC 0006-0461 0006-0461-12 2 CAPSULE in 1 DOSE PACK (0006-0461-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength80MG
Approval Date:Mar 26, 2003TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Sep 26, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR THE PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH CHEMOTHERAPY
Patent:⤷  Try a TrialPatent Expiration:Sep 26, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength125MG
Approval Date:Mar 26, 2003TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Sep 26, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR THE PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH CHEMOTHERAPY

Expired US Patents for NDA 021549

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck EMEND aprepitant CAPSULE;ORAL 021549-001 Mar 26, 2003 ⤷  Try a Trial ⤷  Try a Trial
Merck EMEND aprepitant CAPSULE;ORAL 021549-002 Mar 26, 2003 ⤷  Try a Trial ⤷  Try a Trial
Merck EMEND aprepitant CAPSULE;ORAL 021549-003 Jun 30, 2006 ⤷  Try a Trial ⤷  Try a Trial
Merck EMEND aprepitant CAPSULE;ORAL 021549-002 Mar 26, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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