Details for New Drug Application (NDA): 216848
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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 216848
Tradename: | ATORVASTATIN CALCIUM |
Applicant: | Lepu Pharm |
Ingredient: | atorvastatin calcium |
Patents: | 0 |
Pharmacology for NDA: 216848
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for 216848
Suppliers and Packaging for NDA: 216848
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 216848 | ANDA | Lepu Pharmaceutical Technology Co., Ltd. | 82137-016 | 82137-016-01 | 90 TABLET, FILM COATED in 1 BOTTLE (82137-016-01) |
ATORVASTATIN CALCIUM | atorvastatin calcium | TABLET;ORAL | 216848 | ANDA | Lepu Pharmaceutical Technology Co., Ltd. | 82137-017 | 82137-017-01 | 90 TABLET, FILM COATED in 1 BOTTLE (82137-017-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Nov 3, 2022 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Nov 3, 2022 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Nov 3, 2022 | TE: | RLD: | No |
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