Details for New Drug Application (NDA): 212103
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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-three suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
Summary for 212103
Tradename: | ATORVASTATIN CALCIUM |
Applicant: | Cadila Pharms Ltd |
Ingredient: | atorvastatin calcium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212103
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 212103
Suppliers and Packaging for NDA: 212103
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 212103 | ANDA | Cadila Pharmaceuticals Limited | 71209-090 | 71209-090-04 | 90 TABLET, COATED in 1 BOTTLE (71209-090-04) |
ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 212103 | ANDA | Cadila Pharmaceuticals Limited | 71209-091 | 71209-091-04 | 90 TABLET, COATED in 1 BOTTLE (71209-091-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Oct 16, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Oct 16, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Oct 16, 2023 | TE: | AB | RLD: | No |
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