Details for New Drug Application (NDA): 021316
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NDA 021316 describes ALTOPREV, which is a drug marketed by Covis and is included in one NDA. It is available from one supplier. Additional details are available on the ALTOPREV profile page.
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.
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 | 021316-002 | Jun 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | ALTOPREV | lovastatin | TABLET, EXTENDED RELEASE;ORAL | 021316-003 | Jun 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| 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 | 021316-003 | Jun 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Covis | ALTOPREV | lovastatin | TABLET, EXTENDED RELEASE;ORAL | 021316-002 | Jun 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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