Details for New Drug Application (NDA): 217880
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NDA 217880 describes MARAVIROC, which is a drug marketed by Hetero Labs Ltd Iii, I 3 Pharms, Navinta Llc, and Rhodes Pharms, and is included in four NDAs. It is available from seven 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. Nine 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. Nine suppliers are listed for this compound. Additional details are available on the maraviroc profile page.
Summary for 217880
| Tradename: | MARAVIROC |
| Applicant: | Navinta Llc |
| Ingredient: | maraviroc |
| Patents: | 0 |
Pharmacology for NDA: 217880
| Mechanism of Action | Chemokine Co-receptor 5 Antagonists |
Suppliers and Packaging for NDA: 217880
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MARAVIROC | maraviroc | TABLET;ORAL | 217880 | ANDA | Navinta LLC | 68475-007 | 68475-007-01 | 60 TABLET, FILM COATED in 1 BOTTLE (68475-007-01) |
| MARAVIROC | maraviroc | TABLET;ORAL | 217880 | ANDA | Navinta LLC | 68475-008 | 68475-008-01 | 60 TABLET, FILM COATED in 1 BOTTLE (68475-008-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | May 13, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | May 13, 2025 | TE: | AB | RLD: | No | ||||
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