Details for New Drug Application (NDA): 022128
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The generic ingredient in SELZENTRY is maraviroc. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the maraviroc profile page.
Summary for 022128
Tradename: | SELZENTRY |
Applicant: | Viiv Hlthcare |
Ingredient: | maraviroc |
Patents: | 2 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022128
Mechanism of Action | Chemokine Co-receptor 5 Antagonists |
Suppliers and Packaging for NDA: 022128
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SELZENTRY | maraviroc | TABLET;ORAL | 022128 | NDA | ViiV Healthcare Company | 49702-223 | 49702-223-18 | 60 TABLET, FILM COATED in 1 BOTTLE (49702-223-18) |
SELZENTRY | maraviroc | TABLET;ORAL | 022128 | NDA | ViiV Healthcare Company | 49702-224 | 49702-224-18 | 60 TABLET, FILM COATED in 1 BOTTLE (49702-224-18) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Aug 6, 2007 | TE: | AB | RLD: | Yes | ||||
Patent: | See Plans and Pricing | Patent Expiration: | Feb 6, 2022 | Product Flag? | Substance Flag? | Delist Request? | |||
Patent: | See Plans and Pricing | Patent Expiration: | May 25, 2023 | Product Flag? | Substance Flag? | Delist Request? | Y |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Aug 6, 2007 | TE: | AB | RLD: | Yes | ||||
Patent: | See Plans and Pricing | Patent Expiration: | Feb 6, 2022 | Product Flag? | Substance Flag? | Delist Request? |
Expired US Patents for NDA 022128
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-002 | Aug 6, 2007 | See Plans and Pricing | See Plans and Pricing |
Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-004 | Nov 4, 2016 | See Plans and Pricing | See Plans and Pricing |
Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-003 | Nov 4, 2016 | See Plans and Pricing | See Plans and Pricing |
Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-001 | Aug 6, 2007 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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