Details for New Drug Application (NDA): 019766
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NDA 019766 describes ZOCOR, which is a drug marketed by Organon and is included in one NDA. It is available from one supplier. Additional details are available on the ZOCOR profile page.
The generic ingredient in ZOCOR is simvastatin. There are forty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
The generic ingredient in ZOCOR is simvastatin. There are forty drug master file entries for this compound. Thirty 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 | ||||
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