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Details for New Drug Application (NDA): 021785
The generic ingredient in INVIRASE is saquinavir mesylate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the saquinavir mesylate profile page.
Summary for 021785
Tradename: | INVIRASE |
Applicant: | Hoffmann-la Roche |
Ingredient: | saquinavir mesylate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021785
Mechanism of Action | HIV Protease Inhibitors Cytochrome P450 3A Inhibitors |
Suppliers and Packaging for NDA: 021785
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
INVIRASE | saquinavir mesylate | TABLET;ORAL | 021785 | NDA | Genentech, Inc. | 0004-0244 | 0004-0244-51 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-0244-51) |
INVIRASE | saquinavir mesylate | TABLET;ORAL | 021785 | NDA | State of Florida DOH Central Pharmacy | 53808-0674 | 53808-0674-1 | 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0674-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
Approval Date: | Dec 17, 2004 | TE: | RLD: | Yes |
Expired US Patents for NDA 021785
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Hoffmann-la Roche | INVIRASE | saquinavir mesylate | TABLET;ORAL | 021785-001 | Dec 17, 2004 | ➤ Sign Up | ➤ Sign Up |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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