Details for New Drug Application (NDA): 019766
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The generic ingredient in ZOCOR is simvastatin. There are forty drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
Summary for 019766
Tradename: | ZOCOR |
Applicant: | Organon |
Ingredient: | simvastatin |
Patents: | 0 |
Pharmacology for NDA: 019766
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 019766
Suppliers and Packaging for NDA: 019766
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOCOR | simvastatin | TABLET;ORAL | 019766 | NDA | Organon LLC | 78206-180 | 78206-180-01 | 30 TABLET, FILM COATED in 1 BOTTLE (78206-180-01) |
ZOCOR | simvastatin | TABLET;ORAL | 019766 | NDA | Organon LLC | 78206-180 | 78206-180-02 | 90 TABLET, FILM COATED in 1 BOTTLE (78206-180-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 23, 1991 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 23, 1991 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Dec 23, 1991 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 019766
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | ZOCOR | simvastatin | TABLET;ORAL | 019766-005 | Jul 10, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Organon | ZOCOR | simvastatin | TABLET;ORAL | 019766-004 | Dec 23, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Organon | ZOCOR | simvastatin | TABLET;ORAL | 019766-001 | Dec 23, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Organon | ZOCOR | simvastatin | TABLET;ORAL | 019766-002 | Dec 23, 1991 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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