Application 076187

Type: ANDA
Sponsor: MYLAN

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	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	Yes
012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.137MG **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	RLD / RS	Approval date
A076187-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05
A076187-011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	RS	2002-06-05
A076187-012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2006-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076187-001	AB1
A076187-001	AB2
A076187-001	AB3
A076187-001	AB4
A076187-002	AB1
A076187-002	AB2
A076187-002	AB3
A076187-002	AB4
A076187-003	AB1
A076187-003	AB2
A076187-003	AB3
A076187-003	AB4
A076187-004	AB1
A076187-004	AB2
A076187-004	AB3
A076187-004	AB4
A076187-005	AB1
A076187-005	AB2
A076187-005	AB3
A076187-005	AB4
A076187-006	AB1
A076187-006	AB2
A076187-006	AB3
A076187-006	AB4
A076187-007	AB1
A076187-007	AB2
A076187-007	AB3
A076187-007	AB4
A076187-008	AB1
A076187-008	AB2
A076187-008	AB3
A076187-008	AB4
A076187-009	AB1
A076187-009	AB2
A076187-009	AB3
A076187-009	AB4
A076187-010	AB1
A076187-010	AB2
A076187-010	AB3
A076187-010	AB4
A076187-011	AB1
A076187-011	AB2
A076187-011	AB3
A076187-011	AB4
A076187-012	AB1
A076187-012	AB2
A076187-012	AB3
A076187-012	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 13 · 492 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076187-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-008	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-009	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-010	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-011	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	RS	2002-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-012	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2006-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-008	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-009	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-010	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-011	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	RS	2002-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076187-012	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2006-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076187-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-008	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-009	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-010	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-011	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4	RS	2002-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076187-012	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2006-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076187-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076187-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076187-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076187-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB1,AB2,AB3,AB4		2002-06-05	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 50 · 1,968 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	A076187-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-001	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-001	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-001	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-002	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-002	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-002	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-003	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-003	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-003	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-004	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-004	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-004	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-005	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-005	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-005	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-005	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-006	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-006	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-006	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-006	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-007	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-007	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-007	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-007	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-008	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-008	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-008	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-008	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-009	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-009	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-009	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-009	AB4	4	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-010	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-010	AB2	2	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-010	AB3	3	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076187-010	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Cardinal Health 107, LLC	66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	db10e666-6204-56cc-e053-2995a90a9e08	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	fa15ac73-f4f6-7a6b-e053-6294a90a4f4e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Mylan Institutional Inc.	cd69c192-cd3f-47e6-b0a6-c536ffed5c4b	2025-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Mylan Institutional Inc.	5723c7a7-2a1d-4ab6-bf39-b2165ae781a6	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Mylan Pharmaceuticals Inc.	e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc	2024-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076187 application number: ANDA076187 ndc (product): 0378-1817 ndc (product): 0378-1805 ndc (product): 0378-1813 ndc (product): 0378-1815 ndc (product): 0378-1811 ndc (product): 0378-1807 ndc (product): 0378-1800 ndc (product): 0378-1803 ndc (product): 0378-1819 ndc (product): 0378-1809

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 188 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1800	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1800	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1800	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1800	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1800	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1800	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1800	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1800	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1803	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1803	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1803	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1803	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1803	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1803	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1803	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1803	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1805	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1805	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1805	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1805	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1805	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1805	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1805	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1805	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1807	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1807	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1807	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1807	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1807	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1807	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1807	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1807	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1809	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1809	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1809	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1809	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1809	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1809	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1809	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1809	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1811	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1811	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1811	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1811	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1811	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1811	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1811	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1811	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1813	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1813	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1813	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1813	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1813	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1813	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1813	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1813	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1815	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1815	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1815	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1815	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1815	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1815	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1815	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1815	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1817	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1817	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1817	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1817	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1817	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1817	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1817	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1817	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1819	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1819	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1819	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1819	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1819	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1819	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1819	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1819	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43061	ORIG	2005-05-10
22544	SUPPL	2005-05-10
39509	ORIG	2004-02-18
22543	ORIG	2004-02-18
8875	ORIG	2004-02-18