Details for New Drug Application (NDA): 020685
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The generic ingredient in CRIXIVAN is indinavir sulfate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the indinavir sulfate profile page.
Summary for 020685
Tradename: | CRIXIVAN |
Applicant: | Merck Sharp Dohme |
Ingredient: | indinavir sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020685
Mechanism of Action | Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors |
Medical Subject Heading (MeSH) Categories for 020685
Suppliers and Packaging for NDA: 020685
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685 | NDA | Merck Sharp & Dohme Corp. | 0006-0571 | 0006-0571-43 | 360 CAPSULE in 1 BOTTLE (0006-0571-43) |
CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685 | NDA | Merck Sharp & Dohme Corp. | 0006-0573 | 0006-0573-62 | 180 CAPSULE in 1 BOTTLE (0006-0573-62) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 400MG BASE | ||||
Approval Date: | Mar 13, 1996 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
Approval Date: | Mar 13, 1996 | TE: | RLD: | Yes |
Profile for product number 005
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 333MG BASE | ||||
Approval Date: | Dec 17, 1998 | TE: | RLD: | No |
Expired US Patents for NDA 020685
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck Sharp Dohme | CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685-005 | Dec 17, 1998 | See Plans and Pricing | See Plans and Pricing |
Merck Sharp Dohme | CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685-006 | Apr 19, 2000 | See Plans and Pricing | See Plans and Pricing |
Merck Sharp Dohme | CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685-006 | Apr 19, 2000 | See Plans and Pricing | See Plans and Pricing |
Merck Sharp Dohme | CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685-003 | Mar 13, 1996 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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