Home Applications 206015 Application 206015
Type ANDA
Sponsor AUROBINDO PHARMA LTD 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 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 A206015-001 PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2016-12-20 A206015-002 PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 A206015-003 PITAVASTATIN CALCIUM PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2016-12-20
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.
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 A206015-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206015-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2016-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206015-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2016-12-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206015-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206015-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2016-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206015-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2016-12-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206015-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206015-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2016-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206015-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2016-12-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206015-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206015-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2016-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206015-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2016-12-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206015-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206015-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2016-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206015-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2016-12-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206015-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206015-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2016-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206015-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2016-12-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206015-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206015-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2016-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206015-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2016-12-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206015-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206015-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2016-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206015-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2016-12-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206015-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206015-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2016-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206015-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2016-12-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206015-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206015-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2016-12-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206015-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2016-12-20 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206015-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206015-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2016-12-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206015-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2016-12-20 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A206015-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A206015-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2016-12-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206015-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2016-12-20 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A206015-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A206015-003 PITAVASTATIN CALCIUM EQ 4MG BASE TABLET / ORAL AB 2016-12-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206015-001 PITAVASTATIN CALCIUM EQ 1MG BASE TABLET / ORAL AB 2016-12-20 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A206015-002 PITAVASTATIN CALCIUM EQ 2MG BASE TABLET / ORAL AB 2016-12-20 c0c555d07b60…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Observed Orange Book exclusivity 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.
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 47078 ORIG 2017-01-31 46484 ORIG 2016-12-22