Details for New Drug Application (NDA): 022023
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NDA 022023 describes EMEND, which is a drug marketed by MSD, 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 suppliers are listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.
The generic ingredient in EMEND is fosaprepitant dimeglumine. There are eleven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.
Summary for 022023
| Tradename: | EMEND |
| Applicant: | Merck And Co Inc |
| Ingredient: | fosaprepitant dimeglumine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 022023
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EMEND | fosaprepitant dimeglumine | POWDER;INTRAVENOUS | 022023 | NDA | Merck Sharp & Dohme LLC | 0006-3061 | 0006-3061-00 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3061-00) / 5 mL in 1 VIAL, SINGLE-DOSE (0006-3061-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 25, 2008 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 2, 2025 | ||||||||
| Regulatory Exclusivity Use: | ADDITION OF A 3-DAY FOSAPREPITANT FOR INJECTION INTRAVENOUS DOSING REGIMEN IN PEDIATRIC PATIENTS FOR THE CURRENTLY APPROVED PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 150MG BASE/VIAL | ||||
| Approval Date: | Nov 12, 2010 | TE: | AP | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | May 2, 2025 | ||||||||
| Regulatory Exclusivity Use: | ADDITION OF A 3-DAY FOSAPREPITANT FOR INJECTION INTRAVENOUS DOSING REGIMEN IN PEDIATRIC PATIENTS FOR THE CURRENTLY APPROVED PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING | ||||||||
Expired US Patents for NDA 022023
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck And Co Inc | EMEND | fosaprepitant dimeglumine | POWDER;INTRAVENOUS | 022023-002 | Nov 12, 2010 | ⤷ Get Started Free | ⤷ Get Started Free |
| Merck And Co Inc | EMEND | fosaprepitant dimeglumine | POWDER;INTRAVENOUS | 022023-001 | Jan 25, 2008 | ⤷ Get Started Free | ⤷ Get Started Free |
| Merck And Co Inc | EMEND | fosaprepitant dimeglumine | POWDER;INTRAVENOUS | 022023-002 | Nov 12, 2010 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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