Application 076752

Type: ANDA
Sponsor: MERCK KGAA

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	0.15MG	No	No
009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.175MG	No	No
010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.2MG	No	No
011	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 · 11 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076752-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.025MG	TABLET / ORAL	2005-06-16
A076752-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.05MG	TABLET / ORAL	2005-06-16
A076752-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG	TABLET / ORAL	2005-06-16
A076752-004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.088MG	TABLET / ORAL	2005-06-16
A076752-005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.1MG	TABLET / ORAL	2005-06-16
A076752-006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG	TABLET / ORAL	2005-06-16
A076752-007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.125MG	TABLET / ORAL	2005-06-16
A076752-008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG	TABLET / ORAL	2005-06-16
A076752-009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG	TABLET / ORAL	2005-06-16
A076752-010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG	TABLET / ORAL	2005-06-16
A076752-011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.3MG	TABLET / ORAL	2005-06-16

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 12 · 473 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	A076752-001	LEVOTHYROXINE SODIUM	0.025MG	TABLET / ORAL	2005-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076752-002	LEVOTHYROXINE SODIUM	0.05MG	TABLET / ORAL	2005-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076752-003	LEVOTHYROXINE SODIUM	0.075MG	TABLET / ORAL	2005-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076752-004	LEVOTHYROXINE SODIUM	0.088MG	TABLET / ORAL	2005-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076752-005	LEVOTHYROXINE SODIUM	0.1MG	TABLET / ORAL	2005-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076752-006	LEVOTHYROXINE SODIUM	0.112MG	TABLET / ORAL	2005-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076752-007	LEVOTHYROXINE SODIUM	0.125MG	TABLET / ORAL	2005-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076752-008	LEVOTHYROXINE SODIUM	0.15MG	TABLET / ORAL	2005-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076752-009	LEVOTHYROXINE SODIUM	0.175MG	TABLET / ORAL	2005-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076752-010	LEVOTHYROXINE SODIUM	0.2MG	TABLET / ORAL	2005-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076752-011	LEVOTHYROXINE SODIUM	0.3MG	TABLET / ORAL	2005-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076752-001	LEVOTHYROXINE SODIUM	0.025MG	TABLET / ORAL	2005-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076752-002	LEVOTHYROXINE SODIUM	0.05MG	TABLET / ORAL	2005-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076752-003	LEVOTHYROXINE SODIUM	0.075MG	TABLET / ORAL	2005-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076752-004	LEVOTHYROXINE SODIUM	0.088MG	TABLET / ORAL	2005-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076752-005	LEVOTHYROXINE SODIUM	0.1MG	TABLET / ORAL	2005-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076752-006	LEVOTHYROXINE SODIUM	0.112MG	TABLET / ORAL	2005-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076752-007	LEVOTHYROXINE SODIUM	0.125MG	TABLET / ORAL	2005-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076752-008	LEVOTHYROXINE SODIUM	0.15MG	TABLET / ORAL	2005-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076752-009	LEVOTHYROXINE SODIUM	0.175MG	TABLET / ORAL	2005-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076752-010	LEVOTHYROXINE SODIUM	0.2MG	TABLET / ORAL	2005-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076752-011	LEVOTHYROXINE SODIUM	0.3MG	TABLET / ORAL	2005-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076752-001	LEVOTHYROXINE SODIUM	0.025MG	TABLET / ORAL	2005-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076752-002	LEVOTHYROXINE SODIUM	0.05MG	TABLET / ORAL	2005-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076752-003	LEVOTHYROXINE SODIUM	0.075MG	TABLET / ORAL	2005-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076752-004	LEVOTHYROXINE SODIUM	0.088MG	TABLET / ORAL	2005-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076752-005	LEVOTHYROXINE SODIUM	0.1MG	TABLET / ORAL	2005-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076752-006	LEVOTHYROXINE SODIUM	0.112MG	TABLET / ORAL	2005-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076752-007	LEVOTHYROXINE SODIUM	0.125MG	TABLET / ORAL	2005-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076752-008	LEVOTHYROXINE SODIUM	0.15MG	TABLET / ORAL	2005-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076752-009	LEVOTHYROXINE SODIUM	0.175MG	TABLET / ORAL	2005-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076752-010	LEVOTHYROXINE SODIUM	0.2MG	TABLET / ORAL	2005-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076752-011	LEVOTHYROXINE SODIUM	0.3MG	TABLET / ORAL	2005-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076752-001	LEVOTHYROXINE SODIUM	0.025MG	TABLET / ORAL	2005-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076752-002	LEVOTHYROXINE SODIUM	0.05MG	TABLET / ORAL	2005-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076752-003	LEVOTHYROXINE SODIUM	0.075MG	TABLET / ORAL	2005-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076752-004	LEVOTHYROXINE SODIUM	0.088MG	TABLET / ORAL	2005-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076752-005	LEVOTHYROXINE SODIUM	0.1MG	TABLET / ORAL	2005-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076752-006	LEVOTHYROXINE SODIUM	0.112MG	TABLET / ORAL	2005-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076752-007	LEVOTHYROXINE SODIUM	0.125MG	TABLET / ORAL	2005-06-16	`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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Unithroid	LEVOTHYROXINE SODIUM	Amneal Pharmaceuticals LLC	07562e72-7eaa-4ce6-94f0-e08814787e50	2019-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.