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 1 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 2026-10-15 13:18:30 2026-09 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209875-002 NIKITA EQ 2MG BASE TABLET / ORAL RLD 2017-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209875-003 NIKITA EQ 4MG BASE TABLET / ORAL RLD 2017-08-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209875-001 NIKITA EQ 1MG BASE TABLET / ORAL RLD 2017-08-04 79d66fd596c7…
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