Home Applications 205961 Application 205961
Type ANDA
Sponsor AMNEAL PHARMS NY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM TABLET;ORAL EQ 1MG BASE No No 002 PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM TABLET;ORAL EQ 2MG BASE No No 003 PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM TABLET;ORAL EQ 4MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A205961-001 PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2024-08-20 A205961-002 PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2024-08-20 A205961-003 PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2024-08-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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.
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 2026-09-14 22:38:34 2026-08 A205961-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2024-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205961-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2024-08-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205961-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2024-08-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205961-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2024-08-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205961-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2024-08-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205961-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2024-08-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205961-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2024-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205961-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2024-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205961-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2024-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205961-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2024-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205961-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2024-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205961-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2024-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205961-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2024-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205961-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2024-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205961-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2024-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205961-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2024-08-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205961-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2024-08-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205961-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2024-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205961-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2024-08-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205961-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2024-08-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205961-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2024-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205961-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2024-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205961-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2024-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205961-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2024-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205961-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2024-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205961-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2024-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205961-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2024-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205961-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2024-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205961-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2024-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205961-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2024-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205961-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2024-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205961-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2024-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205961-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2024-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205961-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2024-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205961-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2024-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205961-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2024-08-20 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205961-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2024-08-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205961-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2024-08-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205961-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2024-08-20 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Documents# Document, Submission type, Date table Document Submission type Date 54819 ORIG 2018-07-06