Details for New Drug Application (NDA): 217114
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NDA 217114 describes MARAVIROC, which is a drug marketed by Hetero Labs Ltd Iii and I 3 Pharms and is included in two NDAs. It is available from five suppliers. Additional details are available on the MARAVIROC profile page.
The generic ingredient in MARAVIROC is maraviroc. There are two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the maraviroc profile page.
The generic ingredient in MARAVIROC is maraviroc. There are two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the maraviroc profile page.
Summary for 217114
| Tradename: | MARAVIROC |
| Applicant: | I 3 Pharms |
| Ingredient: | maraviroc |
| Patents: | 0 |
Pharmacology for NDA: 217114
| Mechanism of Action | Chemokine Co-receptor 5 Antagonists |
Suppliers and Packaging for NDA: 217114
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MARAVIROC | maraviroc | TABLET;ORAL | 217114 | ANDA | i3 Pharmaceuticals, LLC | 72319-024 | 72319-024-02 | 60 TABLET, FILM COATED in 1 BOTTLE (72319-024-02) |
| MARAVIROC | maraviroc | TABLET;ORAL | 217114 | ANDA | i3 Pharmaceuticals, LLC | 72319-025 | 72319-025-02 | 60 TABLET, FILM COATED in 1 BOTTLE (72319-025-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Aug 17, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Aug 17, 2023 | TE: | AB | RLD: | No | ||||
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