Home Applications 209875 Application 209875
Type NDA
Sponsor LUPIN LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NIKITA PITAVASTATIN SODIUM TABLET;ORAL EQ 1MG BASE Yes No 002 NIKITA PITAVASTATIN SODIUM TABLET;ORAL EQ 2MG BASE Yes No 003 NIKITA PITAVASTATIN SODIUM TABLET;ORAL EQ 4MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209875-001 NIKITA PITAVASTATIN SODIUM EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 N209875-002 NIKITA PITAVASTATIN SODIUM EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 N209875-003 NIKITA PITAVASTATIN SODIUM EQ 4MG BASE TABLET / ORAL RLD 2017-08-04
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 2 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 c0c555d07b60…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 76007 SUPPL 2023-10-31 75992 SUPPL 2023-10-31 64720 SUPPL 2020-09-29 64709 SUPPL 2020-09-28 62837 SUPPL 2020-05-06 62833 SUPPL 2020-05-06 49851 ORIG 2017-09-25 49278 ORIG 2017-08-08 49275 ORIG 2017-08-08