Details for New Drug Application (NDA): 209875
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The generic ingredient in NIKITA is pitavastatin sodium. There are fifteen drug master file entries for this compound. Additional details are available on the pitavastatin sodium profile page.
Summary for 209875
Tradename: | NIKITA |
Applicant: | Lupin Ltd |
Ingredient: | pitavastatin sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
Approval Date: | Aug 4, 2017 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | Aug 4, 2017 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Aug 4, 2017 | TE: | RLD: | Yes |
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