Details for New Drug Application (NDA): 205961
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The generic ingredient in PITAVASTATIN CALCIUM is pitavastatin calcium. There are fifteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the pitavastatin calcium profile page.
Summary for 205961
Tradename: | PITAVASTATIN CALCIUM |
Applicant: | Amneal Pharms Ny |
Ingredient: | pitavastatin calcium |
Patents: | 0 |
Pharmacology for NDA: 205961
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Suppliers and Packaging for NDA: 205961
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 205961 | ANDA | Amneal Pharmaceuticals LLC | 65162-029 | 65162-029-03 | 30 TABLET, FILM COATED in 1 BOTTLE (65162-029-03) |
PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 205961 | ANDA | Amneal Pharmaceuticals LLC | 65162-029 | 65162-029-09 | 90 TABLET, FILM COATED in 1 BOTTLE (65162-029-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
Approval Date: | Aug 20, 2024 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | Aug 20, 2024 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Aug 20, 2024 | TE: | AB | RLD: | No |
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