Details for New Drug Application (NDA): 206047
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NDA 206047 describes PITAVASTATIN CALCIUM, which is a drug marketed by Amneal Pharms Ny, Aurobindo Pharma, Hetero Labs Ltd V, Lupin Ltd, Mylan, Orient Pharma Co Ltd, Sawai Usa, and Zydus Pharms, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the PITAVASTATIN CALCIUM profile page.
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.
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 206047
| Tradename: | PITAVASTATIN CALCIUM |
| Applicant: | Zydus Pharms |
| Ingredient: | pitavastatin calcium |
| Patents: | 0 |
Pharmacology for NDA: 206047
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Suppliers and Packaging for NDA: 206047
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 206047 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-481 | 68382-481-16 | 90 TABLET in 1 BOTTLE (68382-481-16) |
| PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 206047 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-482 | 68382-482-16 | 90 TABLET in 1 BOTTLE (68382-482-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Feb 22, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Feb 22, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | Feb 22, 2023 | TE: | AB | RLD: | No | ||||
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