Details for New Drug Application (NDA): 021316
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The generic ingredient in ALTOPREV is lovastatin. There are thirty-three drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the lovastatin profile page.
Summary for 021316
Tradename: | ALTOPREV |
Applicant: | Covis |
Ingredient: | lovastatin |
Patents: | 0 |
Pharmacology for NDA: 021316
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 021316
Suppliers and Packaging for NDA: 021316
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALTOPREV | lovastatin | TABLET, EXTENDED RELEASE;ORAL | 021316 | NDA | Covis Pharma US, Inc | 70515-628 | 70515-628-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70515-628-30) |
ALTOPREV | lovastatin | TABLET, EXTENDED RELEASE;ORAL | 021316 | NDA | Covis Pharma US, Inc | 70515-629 | 70515-629-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70515-629-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
Approval Date: | Jun 26, 2002 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 20MG | ||||
Approval Date: | Jun 26, 2002 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 40MG | ||||
Approval Date: | Jun 26, 2002 | TE: | RLD: | Yes |
Expired US Patents for NDA 021316
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Covis | ALTOPREV | lovastatin | TABLET, EXTENDED RELEASE;ORAL | 021316-004 | Jun 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Covis | ALTOPREV | lovastatin | TABLET, EXTENDED RELEASE;ORAL | 021316-001 | Jun 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Covis | ALTOPREV | lovastatin | TABLET, EXTENDED RELEASE;ORAL | 021316-002 | Jun 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Covis | ALTOPREV | lovastatin | TABLET, EXTENDED RELEASE;ORAL | 021316-002 | Jun 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Covis | ALTOPREV | lovastatin | TABLET, EXTENDED RELEASE;ORAL | 021316-003 | Jun 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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