Application 207588

Type: ANDA
Sponsor: WATSON LABS TEVA

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 1.

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
A207588-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10
A207588-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10
A207588-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10
A207588-004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10
A207588-005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10
A207588-006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10
A207588-007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10
A207588-008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10
A207588-009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10
A207588-010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10
A207588-011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10
A207588-012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207588-001	AB1
A207588-001	AB2
A207588-001	AB3
A207588-001	AB4
A207588-002	AB1
A207588-002	AB2
A207588-002	AB3
A207588-002	AB4
A207588-003	AB1
A207588-003	AB2
A207588-003	AB3
A207588-003	AB4
A207588-004	AB1
A207588-004	AB2
A207588-004	AB3
A207588-004	AB4
A207588-005	AB1
A207588-005	AB2
A207588-005	AB3
A207588-005	AB4
A207588-006	AB1
A207588-006	AB2
A207588-006	AB3
A207588-006	AB4
A207588-007	AB1
A207588-007	AB2
A207588-007	AB3
A207588-007	AB4
A207588-008	AB1
A207588-008	AB2
A207588-008	AB3
A207588-008	AB4
A207588-009	AB1
A207588-009	AB2
A207588-009	AB3
A207588-009	AB4
A207588-010	AB1
A207588-010	AB2
A207588-010	AB3
A207588-010	AB4
A207588-011	AB1
A207588-011	AB2
A207588-011	AB3
A207588-011	AB4
A207588-012	AB1
A207588-012	AB2
A207588-012	AB3
A207588-012	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 9 · 348 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
2026-02-19 14:30 UTC	2026-02	A207588-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207588-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207588-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207588-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207588-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207588-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207588-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207588-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207588-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207588-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207588-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207588-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207588-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207588-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207588-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207588-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207588-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207588-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207588-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207588-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207588-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207588-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207588-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207588-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207588-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207588-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207588-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207588-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207588-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	2022-05-10	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 24 · 960 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207588-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-001	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-001	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-001	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-002	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-002	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-002	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-003	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-003	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-003	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-004	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-004	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-004	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-005	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-005	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-005	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-006	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-006	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-006	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-006	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-007	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-007	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-007	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-007	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-008	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-008	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-008	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-008	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-009	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-009	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-009	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-009	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-010	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-010	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-010	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207588-010	AB4	4	`011fe1cb6892…`

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 1 of 1 · 9 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	52a07ade-4098-477d-874e-dd692667041e	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207588 application number: ANDA207588
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	64aaeba7-1013-44a4-96fc-b876016897b3	2025-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207588 application number: ANDA207588
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	65b266af-72a5-4409-ab55-bd14341135aa	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207588 application number: ANDA207588
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	9ff5ad8e-f28c-4322-be6e-072487878c12	2025-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207588 application number: ANDA207588
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	702016f6-8507-471f-b833-3a582aef5d2e	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207588 application number: ANDA207588
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	a55e735f-a5b0-4b85-9fd7-3a4b6723a81b	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207588 application number: ANDA207588
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	e1f77539-2156-4890-baca-8b13779c745c	2024-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207588 application number: ANDA207588
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	b4f8dfd0-b15a-4da5-a0d0-ad768e0b7ff8	2024-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207588 application number: ANDA207588
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Teva Pharmaceuticals, Inc.	60cadfd7-82b5-4207-97e1-1dd0655efb27	2024-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207588 application number: ANDA207588 ndc (product): 0480-8715 ndc (product): 0480-8704 ndc (product): 0480-8687 ndc (product): 0480-8710 ndc (product): 0480-8693 ndc (product): 0480-8707 ndc (product): 0480-8718 ndc (product): 0480-8722 ndc (product): 0480-8690 ndc (product): 0480-8725 ndc (product): 0480-8682 ndc (product): 0480-8701

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0480-8682	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8682	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8682	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8687	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8687	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8687	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8690	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8690	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8690	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8693	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8693	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8693	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8701	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8701	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8701	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8704	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8704	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8704	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8707	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8707	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8707	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8710	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8710	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8710	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8715	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8715	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8715	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8718	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8718	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8718	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8722	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8722	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8722	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8725	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8725	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current
0480-8725	Levothyroxine sodium	Levothyroxine sodium	Teva Pharmaceuticals, Inc.	ANDA	Current