Home Applications 213256 Application 213256
Type ANDA
Sponsor TEVA PHARMS USA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM CAPSULE;ORAL 0.088MG No No 002 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM CAPSULE;ORAL 0.1MG No No 003 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM CAPSULE;ORAL 0.125MG 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 A213256-001 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.088MG CAPSULE / ORAL 2021-01-06 A213256-002 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.1MG CAPSULE / ORAL 2021-01-06 A213256-003 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.125MG CAPSULE / ORAL 2021-01-06
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 3 · 111 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 2026-09-14 22:38:34 2026-08 A213256-001 LEVOTHYROXINE SODIUM 0.088MG CAPSULE / ORAL 2021-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213256-002 LEVOTHYROXINE SODIUM 0.1MG CAPSULE / ORAL 2021-01-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213256-003 LEVOTHYROXINE SODIUM 0.125MG CAPSULE / ORAL 2021-01-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213256-001 LEVOTHYROXINE SODIUM 0.088MG CAPSULE / ORAL 2021-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213256-002 LEVOTHYROXINE SODIUM 0.1MG CAPSULE / ORAL 2021-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213256-003 LEVOTHYROXINE SODIUM 0.125MG CAPSULE / ORAL 2021-01-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213256-001 LEVOTHYROXINE SODIUM 0.088MG CAPSULE / ORAL 2021-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213256-002 LEVOTHYROXINE SODIUM 0.1MG CAPSULE / ORAL 2021-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213256-003 LEVOTHYROXINE SODIUM 0.125MG CAPSULE / ORAL 2021-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213256-001 LEVOTHYROXINE SODIUM 0.088MG CAPSULE / ORAL 2021-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213256-002 LEVOTHYROXINE SODIUM 0.1MG CAPSULE / ORAL 2021-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213256-003 LEVOTHYROXINE SODIUM 0.125MG CAPSULE / ORAL 2021-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213256-001 LEVOTHYROXINE SODIUM 0.088MG CAPSULE / ORAL 2021-01-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213256-002 LEVOTHYROXINE SODIUM 0.1MG CAPSULE / ORAL 2021-01-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213256-003 LEVOTHYROXINE SODIUM 0.125MG CAPSULE / ORAL 2021-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213256-001 LEVOTHYROXINE SODIUM 0.088MG CAPSULE / ORAL 2021-01-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213256-002 LEVOTHYROXINE SODIUM 0.1MG CAPSULE / ORAL 2021-01-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213256-003 LEVOTHYROXINE SODIUM 0.125MG CAPSULE / ORAL 2021-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213256-001 LEVOTHYROXINE SODIUM 0.088MG CAPSULE / ORAL 2021-01-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213256-002 LEVOTHYROXINE SODIUM 0.1MG CAPSULE / ORAL 2021-01-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213256-003 LEVOTHYROXINE SODIUM 0.125MG CAPSULE / ORAL 2021-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213256-001 LEVOTHYROXINE SODIUM 0.088MG CAPSULE / ORAL 2021-01-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213256-002 LEVOTHYROXINE SODIUM 0.1MG CAPSULE / ORAL 2021-01-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213256-003 LEVOTHYROXINE SODIUM 0.125MG CAPSULE / ORAL 2021-01-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213256-001 LEVOTHYROXINE SODIUM 0.088MG CAPSULE / ORAL 2021-01-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213256-002 LEVOTHYROXINE SODIUM 0.1MG CAPSULE / ORAL 2021-01-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213256-003 LEVOTHYROXINE SODIUM 0.125MG CAPSULE / ORAL 2021-01-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213256-001 LEVOTHYROXINE SODIUM 0.088MG CAPSULE / ORAL 2021-01-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213256-002 LEVOTHYROXINE SODIUM 0.1MG CAPSULE / ORAL 2021-01-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213256-003 LEVOTHYROXINE SODIUM 0.125MG CAPSULE / ORAL 2021-01-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213256-001 LEVOTHYROXINE SODIUM 0.088MG CAPSULE / ORAL 2021-01-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213256-002 LEVOTHYROXINE SODIUM 0.1MG CAPSULE / ORAL 2021-01-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213256-003 LEVOTHYROXINE SODIUM 0.125MG CAPSULE / ORAL 2021-01-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213256-001 LEVOTHYROXINE SODIUM 0.088MG CAPSULE / ORAL 2021-01-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213256-002 LEVOTHYROXINE SODIUM 0.1MG CAPSULE / ORAL 2021-01-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213256-003 LEVOTHYROXINE SODIUM 0.125MG CAPSULE / ORAL 2021-01-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213256-001 LEVOTHYROXINE SODIUM 0.088MG CAPSULE / ORAL 2021-01-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213256-002 LEVOTHYROXINE SODIUM 0.1MG CAPSULE / ORAL 2021-01-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213256-003 LEVOTHYROXINE SODIUM 0.125MG CAPSULE / ORAL 2021-01-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213256-001 LEVOTHYROXINE SODIUM 0.088MG CAPSULE / ORAL 2021-01-06 301d65b070ca…
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 15 of 15 · 281 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 66063 ORIG 2021-02-02