Details for New Drug Application (NDA): 020702
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The generic ingredient in LIPITOR is atorvastatin calcium. There is one drug master file entry for this compound. Sixty suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
Summary for 020702
| Tradename: | LIPITOR |
| Applicant: | Upjohn |
| Ingredient: | atorvastatin calcium |
| Patents: | 0 |
Pharmacology for NDA: 020702
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 020702
Suppliers and Packaging for NDA: 020702
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702 | NDA | Viatris Specialty LLC | 58151-155 | 58151-155-77 | 90 TABLET, FILM COATED in 1 BOTTLE (58151-155-77) |
| LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702 | NDA | Viatris Specialty LLC | 58151-156 | 58151-156-77 | 90 TABLET, FILM COATED in 1 BOTTLE (58151-156-77) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Dec 17, 1996 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Dec 17, 1996 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Dec 17, 1996 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020702
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-001 | Dec 17, 1996 | 5,385,929 | ⤷ Start Trial |
| Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-004 | Apr 7, 2000 | 5,969,166 | ⤷ Start Trial |
| Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-003 | Dec 17, 1996 | 5,385,929 | ⤷ Start Trial |
| Upjohn | LIPITOR | atorvastatin calcium | TABLET;ORAL | 020702-002 | Dec 17, 1996 | 5,385,929 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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