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	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	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 9 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	2aab0208-81ad-4607-8196-b4dc5ad5fdaa	2025-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	194bc35b-ac82-4a40-bbd4-68eaff50b380	2025-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	37a55040-a9a2-4ff4-8463-9e1c7823d6ff	2025-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	2e242b93-bc4f-405a-a194-1981c721ad94	2025-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	609352a9-740f-4874-997b-60b58d0c2b8a	2025-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	9e588c43-b9b5-478e-99f7-e197add3cd26	2025-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	c1b0fbad-5816-4152-ab59-05079e8c2148	2025-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	9e3bffb9-f66e-4c73-befc-e60d769f6610	2025-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	64aaeba7-1013-44a4-96fc-b876016897b3	2025-07-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Mylan Institutional Inc.	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	2025-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	cfab474d-3272-41fd-a8ec-762dd1a84fa6	2025-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	b9a50170-ac0b-483e-9e85-1d03b12e4f7d	2025-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	REMEDYREPACK INC.	0fa2e2f5-401b-45c1-b6a5-d02f6faf509d	2025-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Mylan Institutional Inc.	5723c7a7-2a1d-4ab6-bf39-b2165ae781a6	2025-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	398a00d0-1247-4f6f-b4c1-dade399cc417	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	70d84fe0-afc4-4ef2-b4d8-f156abac3d1f	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	ff7f5eff-4c90-4aa0-8915-704f92dea8aa	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	412fc3f4-d9e0-49c5-b042-a6010aea7e5e	2025-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
THYQUIDITY	LEVOTHYROXINE SODIUM	Oliva Therapeutics, LLC	0c839877-50e4-455f-9b6c-462efb09cb96	2025-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	884f9fa1-58aa-4ff7-934f-106a0470e747	2025-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM

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