Details for New Drug Application (NDA): 214344
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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 214344
Tradename: | ATORVASTATIN CALCIUM |
Applicant: | Hetero Labs Ltd V |
Ingredient: | atorvastatin calcium |
Patents: | 0 |
Pharmacology for NDA: 214344
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 214344
Suppliers and Packaging for NDA: 214344
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 214344 | ANDA | Camber Pharmaceuticals, Inc. | 31722-424 | 31722-424-05 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-424-05) |
ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 214344 | ANDA | Camber Pharmaceuticals, Inc. | 31722-424 | 31722-424-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (31722-424-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Sep 12, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Sep 12, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Sep 12, 2023 | TE: | AB | RLD: | No |
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