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 14 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	8bc641d8-0185-49b2-9c1f-d886bf5ce098	2023-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	XLCare Pharmaceuticals, Inc.	51a27110-e787-409b-98ba-c6471d0ad5cf	2023-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Camber Pharmaceuticals, Inc.	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	2023-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	2f129a3d-f3e6-45b2-9704-3ad171cbd8a5	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	329b6eb2-4fa3-41f6-a6ff-96d94b7a65bf	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	9d1aaa2d-c8c0-478f-8540-f92f6512cfcb	2022-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	ca197216-83f1-470a-9313-d1b923924661	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	7ceed5ff-fd41-4ebd-ade7-e31b135231c1	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	2daab9ce-0570-4fdf-a7bd-01c3178f8cf3	2021-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	2f0657d5-3e5c-4249-bfaa-7f5ef1528672	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
LEVOXYL	LEVOTHYROXINE SODIUM	Pfizer Laboratories Div Pfizer Inc	758588c3-c63e-491b-0aa2-4f50d80cb174	2020-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Fresenius Kabi USA, LLC	388a1f15-8c1c-46a5-997f-7f326f696b59	2020-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Fresenius Kabi USA, LLC	50b1c8a4-75b6-49c8-80fc-3841ee80b183	2020-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	12ccf2fd-ccf0-4bcf-8eee-e2a16c8b44d6	2020-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	97e28b00-9913-463f-9de2-08c828edbe67	2020-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	05ab038e-45fa-488e-a05e-12a2dd3564c1	2020-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	b81720f9-2836-4c1d-8691-0f6acef13316	2020-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	3019762c-d480-4530-a3b2-762b523e7961	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	434075d5-a82b-4f17-85e6-4c1922663dbc	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	18c7c63a-642e-47fe-a8ee-12aaf652b2aa	2019-10-01	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