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Details for New Drug Application (NDA): 205786
The generic ingredient in ISENTRESS is raltegravir potassium. There are five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.
Summary for 205786
Tradename: | ISENTRESS |
Applicant: | Merck Sharp Dohme |
Ingredient: | raltegravir potassium |
Patents: | 4 |
Therapeutic Class: | Antivirals |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205786
Mechanism of Action | HIV Integrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 205786
Suppliers and Packaging for NDA: 205786
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISENTRESS | raltegravir potassium | POWDER;ORAL | 205786 | NDA | Merck Sharp & Dohme Corp. | 0006-3603 | N | 0006-3603-60 |
ISENTRESS | raltegravir potassium | POWDER;ORAL | 205786 | NDA | Merck Sharp & Dohme Corp. | 0006-3603 | N | 0006-3603-61 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | EQ 100MG BASE/PACKET | ||||
Approval Date: | Dec 20, 2013 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Nov 22, 2020 | ||||||||
Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Regulatory Exclusivity Expiration: | May 22, 2021 | ||||||||
Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Patent: | ➤ Sign Up | Patent Expiration: | Apr 3, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y |
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