Details for New Drug Application (NDA): 214513
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The generic ingredient in ATORVASTATIN CALCIUM is atorvastatin calcium. There are sixty-two drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
Summary for 214513
Tradename: | ATORVASTATIN CALCIUM |
Applicant: | Laurus |
Ingredient: | atorvastatin calcium |
Patents: | 0 |
Pharmacology for NDA: 214513
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 214513
Suppliers and Packaging for NDA: 214513
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 214513 | ANDA | Laurus Labs Limited | 42385-940 | 42385-940-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42385-940-01) |
ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 214513 | ANDA | Laurus Labs Limited | 42385-940 | 42385-940-05 | 500 TABLET, FILM COATED in 1 BOTTLE (42385-940-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Jan 22, 2024 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Jan 22, 2024 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Jan 22, 2024 | TE: | AB | RLD: | No |
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