Home Applications 210831 Application 210831
Type ANDA
Sponsor AMNEAL PHARMS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG No No 002 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG No No 003 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG No No 004 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG No No 005 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG No No 006 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG No No 007 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG No No 008 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG No No 009 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG No No 010 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG No No 011 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG No No 012 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.3MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 12 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210831-001 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.025MG TABLET / ORAL 2019-02-19 A210831-002 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.05MG TABLET / ORAL 2019-02-19 A210831-003 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.075MG TABLET / ORAL 2019-02-19 A210831-004 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.088MG TABLET / ORAL 2019-02-19 A210831-005 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.1MG TABLET / ORAL 2019-02-19 A210831-006 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.112MG TABLET / ORAL 2019-02-19 A210831-007 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.125MG TABLET / ORAL 2019-02-19 A210831-008 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.137MG TABLET / ORAL 2019-02-19 A210831-009 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.15MG TABLET / ORAL 2019-02-19 A210831-010 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.175MG TABLET / ORAL 2019-02-19 A210831-011 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.2MG TABLET / ORAL 2019-02-19 A210831-012 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.3MG TABLET / ORAL 2019-02-19
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 13 · 516 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 A210831-001 LEVOTHYROXINE SODIUM 0.025MG TABLET / ORAL 2019-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210831-002 LEVOTHYROXINE SODIUM 0.05MG TABLET / ORAL 2019-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210831-003 LEVOTHYROXINE SODIUM 0.075MG TABLET / ORAL 2019-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210831-004 LEVOTHYROXINE SODIUM 0.088MG TABLET / ORAL 2019-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210831-005 LEVOTHYROXINE SODIUM 0.1MG TABLET / ORAL 2019-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210831-006 LEVOTHYROXINE SODIUM 0.112MG TABLET / ORAL 2019-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210831-007 LEVOTHYROXINE SODIUM 0.125MG TABLET / ORAL 2019-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210831-008 LEVOTHYROXINE SODIUM 0.137MG TABLET / ORAL 2019-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210831-009 LEVOTHYROXINE SODIUM 0.15MG TABLET / ORAL 2019-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210831-010 LEVOTHYROXINE SODIUM 0.175MG TABLET / ORAL 2019-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210831-011 LEVOTHYROXINE SODIUM 0.2MG TABLET / ORAL 2019-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210831-012 LEVOTHYROXINE SODIUM 0.3MG TABLET / ORAL 2019-02-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210831-001 LEVOTHYROXINE SODIUM 0.025MG TABLET / ORAL 2019-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210831-002 LEVOTHYROXINE SODIUM 0.05MG TABLET / ORAL 2019-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210831-003 LEVOTHYROXINE SODIUM 0.075MG TABLET / ORAL 2019-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210831-004 LEVOTHYROXINE SODIUM 0.088MG TABLET / ORAL 2019-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210831-005 LEVOTHYROXINE SODIUM 0.1MG TABLET / ORAL 2019-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210831-006 LEVOTHYROXINE SODIUM 0.112MG TABLET / ORAL 2019-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210831-007 LEVOTHYROXINE SODIUM 0.125MG TABLET / ORAL 2019-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210831-008 LEVOTHYROXINE SODIUM 0.137MG TABLET / ORAL 2019-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210831-009 LEVOTHYROXINE SODIUM 0.15MG TABLET / ORAL 2019-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210831-010 LEVOTHYROXINE SODIUM 0.175MG TABLET / ORAL 2019-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210831-011 LEVOTHYROXINE SODIUM 0.2MG TABLET / ORAL 2019-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210831-012 LEVOTHYROXINE SODIUM 0.3MG TABLET / ORAL 2019-02-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210831-001 LEVOTHYROXINE SODIUM 0.025MG TABLET / ORAL 2019-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210831-002 LEVOTHYROXINE SODIUM 0.05MG TABLET / ORAL 2019-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210831-003 LEVOTHYROXINE SODIUM 0.075MG TABLET / ORAL 2019-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210831-004 LEVOTHYROXINE SODIUM 0.088MG TABLET / ORAL 2019-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210831-005 LEVOTHYROXINE SODIUM 0.1MG TABLET / ORAL 2019-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210831-006 LEVOTHYROXINE SODIUM 0.112MG TABLET / ORAL 2019-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210831-007 LEVOTHYROXINE SODIUM 0.125MG TABLET / ORAL 2019-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210831-008 LEVOTHYROXINE SODIUM 0.137MG TABLET / ORAL 2019-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210831-009 LEVOTHYROXINE SODIUM 0.15MG TABLET / ORAL 2019-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210831-010 LEVOTHYROXINE SODIUM 0.175MG TABLET / ORAL 2019-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210831-011 LEVOTHYROXINE SODIUM 0.2MG TABLET / ORAL 2019-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210831-012 LEVOTHYROXINE SODIUM 0.3MG TABLET / ORAL 2019-02-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210831-001 LEVOTHYROXINE SODIUM 0.025MG TABLET / ORAL 2019-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210831-002 LEVOTHYROXINE SODIUM 0.05MG TABLET / ORAL 2019-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210831-003 LEVOTHYROXINE SODIUM 0.075MG TABLET / ORAL 2019-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210831-004 LEVOTHYROXINE SODIUM 0.088MG TABLET / ORAL 2019-02-19 31067a03dcf5…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69238-1163 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1163 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1164 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1164 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1168 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1168 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1169 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1169 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1177 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1177 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1178 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1178 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1183 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1183 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1275 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1275 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1276 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1276 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1277 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1277 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1278 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1278 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1279 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current 69238-1279 Levothyroxine Sodium Levothyroxine Sodium Amneal Pharmaceuticals NY LLC ANDA Current