Home Applications 218070 Application 218070
Type ANDA
Sponsor BIOCON PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM TABLET;ORAL EQ 0.005MG BASE No No 002 LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM TABLET;ORAL EQ 0.025MG BASE No No 003 LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM TABLET;ORAL EQ 0.05MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A218070-001 LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET / ORAL AB 2024-02-06 A218070-002 LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET / ORAL AB 2024-02-06 A218070-003 LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET / ORAL AB 2024-02-06
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 1 of 2 · 51 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 2026-02-19 14:30 UTC 2026-02 A218070-001 LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET / ORAL AB 2024-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218070-002 LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET / ORAL AB 2024-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218070-003 LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET / ORAL AB 2024-02-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218070-001 LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET / ORAL AB 2024-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218070-002 LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET / ORAL AB 2024-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218070-003 LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET / ORAL AB 2024-02-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218070-001 LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET / ORAL AB 2024-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218070-002 LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET / ORAL AB 2024-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218070-003 LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET / ORAL AB 2024-02-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218070-001 LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET / ORAL AB 2024-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218070-002 LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET / ORAL AB 2024-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218070-003 LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET / ORAL AB 2024-02-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218070-001 LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET / ORAL AB 2024-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218070-002 LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET / ORAL AB 2024-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218070-003 LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET / ORAL AB 2024-02-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218070-001 LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET / ORAL AB 2024-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218070-002 LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET / ORAL AB 2024-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218070-003 LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET / ORAL AB 2024-02-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218070-001 LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET / ORAL AB 2024-02-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218070-002 LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET / ORAL AB 2024-02-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218070-003 LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET / ORAL AB 2024-02-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218070-001 LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET / ORAL AB 2024-02-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218070-002 LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET / ORAL AB 2024-02-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218070-003 LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET / ORAL AB 2024-02-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218070-001 LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET / ORAL AB 2024-02-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218070-002 LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET / ORAL AB 2024-02-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218070-003 LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET / ORAL AB 2024-02-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218070-001 LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET / ORAL AB 2024-02-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218070-002 LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET / ORAL AB 2024-02-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218070-003 LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET / ORAL AB 2024-02-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218070-001 LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET / ORAL AB 2024-02-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218070-002 LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET / ORAL AB 2024-02-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218070-003 LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET / ORAL AB 2024-02-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218070-001 LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET / ORAL AB 2024-02-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218070-002 LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET / ORAL AB 2024-02-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218070-003 LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET / ORAL AB 2024-02-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218070-001 LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET / ORAL AB 2024-02-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218070-002 LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET / ORAL AB 2024-02-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218070-003 LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET / ORAL AB 2024-02-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218070-001 LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET / ORAL AB 2024-02-06 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 51 observed states.
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.