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 8 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	Northwind Health Company, LLC	da827567-810b-624d-e053-2a95a90a9bde	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	f86fab39-bbd9-a51c-e053-6294a90accd0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	d9dff641-ced3-bae3-e053-2a95a90a2e29	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	472ec9e7-c1db-bf8c-e063-6394a90a2c07	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	e3667ab1-2bd9-4e0d-8a97-f907593e7954	2025-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	eb120047-a43b-40a4-9f55-067b1b51edda	2025-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	2adb05ef-b3fa-4ac2-b219-99442746392b	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	d5b005e8-a88d-450b-bbc3-393d885260f5	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	c29a417b-95b0-4c9b-85e6-ec884049edb1	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	3453af75-8c2e-421f-9a08-24751936df41	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	1af49c9f-93da-4838-899b-9445083a154b	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	fea284d8-0514-498b-a37c-405730b5f6a2	2025-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Coupler LLC	4302e36f-0b5b-f645-e063-6394a90a010f	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	eb149423-070f-49ae-ab18-5afee09d06fb	2025-11-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	48c29432-a36c-4787-a05f-8d25a0abcc37	2025-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Accord Healthcare Inc.	a6233381-3043-4e9a-aaa6-a6b105e5142b	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	bcf10012-8920-4737-92f5-7401ee0c5894	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	00a4fc0b-7162-455e-8ed3-56efdbbe182e	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Piramal Critical Care, Inc.	76139990-1355-cfb6-e053-2991aa0ace5b	2025-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Zydus Pharmaceuticals USA Inc.	bf8a952c-f05b-4814-b55a-ed04be015269	2025-09-16	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