Application 211417

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	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	Approval date
A211417-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21
A211417-012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 48 matching rows.

Application-product, TE code table
Application-product	TE code
A211417-001	AB1
A211417-001	AB2
A211417-001	AB3
A211417-001	AB4
A211417-002	AB1
A211417-002	AB2
A211417-002	AB3
A211417-002	AB4
A211417-003	AB1
A211417-003	AB2
A211417-003	AB3
A211417-003	AB4
A211417-004	AB1
A211417-004	AB2
A211417-004	AB3
A211417-004	AB4
A211417-005	AB1
A211417-005	AB2
A211417-005	AB3
A211417-005	AB4
A211417-006	AB1
A211417-006	AB2
A211417-006	AB3
A211417-006	AB4
A211417-007	AB1
A211417-007	AB2
A211417-007	AB3
A211417-007	AB4
A211417-008	AB1
A211417-008	AB2
A211417-008	AB3
A211417-008	AB4
A211417-009	AB1
A211417-009	AB2
A211417-009	AB3
A211417-009	AB4
A211417-010	AB1
A211417-010	AB2
A211417-010	AB3
A211417-010	AB4
A211417-011	AB1
A211417-011	AB2
A211417-011	AB3
A211417-011	AB4
A211417-012	AB1
A211417-012	AB2
A211417-012	AB3
A211417-012	AB4

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 8 · 312 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211417-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211417-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211417-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211417-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211417-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211417-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-12-21	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 16 · 636 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211417-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-001	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-001	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-002	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-002	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-003	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-003	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-004	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-004	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-005	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-005	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-006	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-006	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-007	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-007	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-008	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-008	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-009	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-009	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-010	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211417-010	AB4	4	`84e616aacf4f…`

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 2 of 2 · 23 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	70dddaf0-f495-495f-95de-36e9efa2e373	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	7ade3f9e-e3d2-401b-a6b7-aa4c9d1c9861	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Macleods Pharmaceuticals Limited	b8c20f76-3ee6-4b29-b77f-ed4ad1baaed9	2024-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211417 application number: ANDA211417 ndc (product): 33342-400 ndc (product): 33342-401 ndc (product): 33342-399 ndc (product): 33342-398 ndc (product): 33342-396 ndc (product): 33342-393 ndc (product): 33342-394 ndc (product): 33342-395 ndc (product): 33342-397 ndc (product): 33342-402 ndc (product): 33342-404 ndc (product): 33342-403

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-393	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Macleods Pharmaceuticals Limited	ANDA	Current
33342-394	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Macleods Pharmaceuticals Limited	ANDA	Current
33342-395	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Macleods Pharmaceuticals Limited	ANDA	Current
33342-396	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Macleods Pharmaceuticals Limited	ANDA	Current
33342-397	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Macleods Pharmaceuticals Limited	ANDA	Current
33342-398	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Macleods Pharmaceuticals Limited	ANDA	Current
33342-399	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Macleods Pharmaceuticals Limited	ANDA	Current
33342-400	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Macleods Pharmaceuticals Limited	ANDA	Current
33342-401	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Macleods Pharmaceuticals Limited	ANDA	Current
33342-402	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Macleods Pharmaceuticals Limited	ANDA	Current
33342-403	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Macleods Pharmaceuticals Limited	ANDA	Current
33342-404	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Macleods Pharmaceuticals Limited	ANDA	Current