Details for New Drug Application (NDA): 206015
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NDA 206015 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 ten 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. Eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the pitavastatin calcium profile page.
Summary for 206015
| Tradename: | PITAVASTATIN CALCIUM |
| Applicant: | Aurobindo Pharma |
| Ingredient: | pitavastatin calcium |
| Patents: | 0 |
Pharmacology for NDA: 206015
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Suppliers and Packaging for NDA: 206015
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 206015 | ANDA | Aurobindo Pharma Limited | 65862-812 | 65862-812-05 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-812-05) |
| PITAVASTATIN CALCIUM | pitavastatin calcium | TABLET;ORAL | 206015 | ANDA | Aurobindo Pharma Limited | 65862-812 | 65862-812-90 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-812-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Dec 20, 2016 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Feb 19, 2024 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Dec 20, 2016 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Feb 19, 2024 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | Dec 20, 2016 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Feb 19, 2024 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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