Application 021116

Type: NDA
Sponsor: ALVOGEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THYRO-TABS	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
002	THYRO-TABS	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
003	THYRO-TABS	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
004	THYRO-TABS	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
005	THYRO-TABS	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
006	THYRO-TABS	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
007	THYRO-TABS	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
008	THYRO-TABS	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
009	THYRO-TABS	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
010	THYRO-TABS	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
011	THYRO-TABS	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	No
012	THYRO-TABS	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	Yes	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	RLD / RS	Approval date
N021116-001	THYRO-TABS	LEVOTHYROXINE SODIUM	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-002	THYRO-TABS	LEVOTHYROXINE SODIUM	0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-003	THYRO-TABS	LEVOTHYROXINE SODIUM	0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-004	THYRO-TABS	LEVOTHYROXINE SODIUM	0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-005	THYRO-TABS	LEVOTHYROXINE SODIUM	0.125MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-006	THYRO-TABS	LEVOTHYROXINE SODIUM	0.15MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-007	THYRO-TABS	LEVOTHYROXINE SODIUM	0.175MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-008	THYRO-TABS	LEVOTHYROXINE SODIUM	0.2MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-009	THYRO-TABS	LEVOTHYROXINE SODIUM	0.3MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-010	THYRO-TABS	LEVOTHYROXINE SODIUM	0.088MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-011	THYRO-TABS	LEVOTHYROXINE SODIUM	0.112MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24
N021116-012	THYRO-TABS	LEVOTHYROXINE SODIUM	0.137MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2004-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021116-001	AB1
N021116-001	AB2
N021116-001	AB3
N021116-001	AB4
N021116-002	AB1
N021116-002	AB2
N021116-002	AB3
N021116-002	AB4
N021116-003	AB1
N021116-003	AB2
N021116-003	AB3
N021116-003	AB4
N021116-004	AB1
N021116-004	AB2
N021116-004	AB3
N021116-004	AB4
N021116-005	AB1
N021116-005	AB2
N021116-005	AB3
N021116-005	AB4
N021116-006	AB1
N021116-006	AB2
N021116-006	AB3
N021116-006	AB4
N021116-007	AB1
N021116-007	AB2
N021116-007	AB3
N021116-007	AB4
N021116-008	AB1
N021116-008	AB2
N021116-008	AB3
N021116-008	AB4
N021116-009	AB1
N021116-009	AB2
N021116-009	AB3
N021116-009	AB4
N021116-010	AB1
N021116-010	AB2
N021116-010	AB3
N021116-010	AB4
N021116-011	AB1
N021116-011	AB2
N021116-011	AB3
N021116-011	AB4
N021116-012	AB1
N021116-012	AB2
N021116-012	AB3
N021116-012	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 · 516 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
2026-09-14 22:38:34	2026-08	N021116-001	THYRO-TABS	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-002	THYRO-TABS	0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-003	THYRO-TABS	0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-004	THYRO-TABS	0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-005	THYRO-TABS	0.125MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-006	THYRO-TABS	0.15MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-007	THYRO-TABS	0.175MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-008	THYRO-TABS	0.2MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-009	THYRO-TABS	0.3MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-010	THYRO-TABS	0.088MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-011	THYRO-TABS	0.112MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-012	THYRO-TABS	0.137MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2004-12-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021116-001	THYRO-TABS	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-002	THYRO-TABS	0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-003	THYRO-TABS	0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-004	THYRO-TABS	0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-005	THYRO-TABS	0.125MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-006	THYRO-TABS	0.15MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-007	THYRO-TABS	0.175MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-008	THYRO-TABS	0.2MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-009	THYRO-TABS	0.3MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-010	THYRO-TABS	0.088MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-011	THYRO-TABS	0.112MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021116-012	THYRO-TABS	0.137MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2004-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021116-001	THYRO-TABS	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-002	THYRO-TABS	0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-003	THYRO-TABS	0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-004	THYRO-TABS	0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-005	THYRO-TABS	0.125MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-006	THYRO-TABS	0.15MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-007	THYRO-TABS	0.175MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-008	THYRO-TABS	0.2MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-009	THYRO-TABS	0.3MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-010	THYRO-TABS	0.088MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-011	THYRO-TABS	0.112MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021116-012	THYRO-TABS	0.137MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2004-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021116-001	THYRO-TABS	0.025MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021116-002	THYRO-TABS	0.05MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021116-003	THYRO-TABS	0.075MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021116-004	THYRO-TABS	0.1MG See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET / ORAL	AB1,AB2,AB3,AB4	RLD	2002-10-24	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 46 · 1,812 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	N021116-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-001	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-001	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-001	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-002	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-002	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-002	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-003	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-003	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-003	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-004	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-004	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-004	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-004	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-005	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-005	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-005	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-005	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-006	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-006	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-006	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-006	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-007	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-007	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-007	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-007	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-008	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-008	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-008	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-008	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-009	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-009	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-009	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-009	AB4	4	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-010	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-010	AB2	2	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-010	AB3	3	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021116-010	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 1 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	3b282e57-1009-4d2c-8ca2-9cca9f791937	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	eb53dc23-8337-497e-b466-192f905563ed	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116 ndc (product): 68788-7704
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	3519c765-2077-4f23-8644-a6242ddbf743	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116 ndc (product): 68788-7764
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	ac10b751-5195-4987-a841-400ae79730f0	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116 ndc (product): 68788-7725
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	645c52bb-c46e-426e-91d4-151aeac975a7	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116 ndc (product): 68788-7729
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	65c8b305-8ffb-4aa5-aca1-f4e4ead71a9c	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116 ndc (product): 68788-7759
levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	f2bed4e7-86e9-430e-80d9-7bd7cfcf9bf5	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	8f7dc71e-4a48-4ba5-945b-f340ff51636e	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	59a99739-2da5-46a7-8811-1169123bed9b	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116 ndc (product): 68788-7698
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	579b1935-77f5-4381-9cb0-e0130e4834e8	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116 ndc (product): 68788-7697
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	4e6dce46-cbf5-4353-9d0c-36b6f857197a	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116 ndc (product): 68788-7724
levothyroxine sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	db5dd9d2-4f96-25d0-e053-2995a90af9dc	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	c9f4923e-5625-1d4f-e053-2a95a90aabc9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Northwind Health Company, LLC	db89c58f-9dd0-b6d6-e053-2a95a90ae2e7	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	48c29432-a36c-4787-a05f-8d25a0abcc37	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	00a4fc0b-7162-455e-8ed3-56efdbbe182e	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116 ndc (product): 71205-353 ndc (product): 71205-354
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	c1b0fbad-5816-4152-ab59-05079e8c2148	2025-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	9e3bffb9-f66e-4c73-befc-e60d769f6610	2025-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116 ndc (product): 71335-1423 ndc (product): 71335-1435 ndc (product): 71335-1447 ndc (product): 71335-1438
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals, Inc.	398a00d0-1247-4f6f-b4c1-dade399cc417	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116 ndc (product): 68788-7689
levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	412fc3f4-d9e0-49c5-b042-a6010aea7e5e	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116

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 2 of 4 · 298 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-8711	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
63629-8712	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
63629-8712	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
68071-2731	levothyroxine sodium	levothyroxine sodium	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-5161	levothyroxine sodium	levothyroxine sodium	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-5161	levothyroxine sodium	levothyroxine sodium	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-5177	levothyroxine sodium	levothyroxine sodium	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-5177	levothyroxine sodium	levothyroxine sodium	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-5226	levothyroxine sodium	levothyroxine sodium	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-5226	levothyroxine sodium	levothyroxine sodium	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-5227	levothyroxine sodium	levothyroxine sodium	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-5227	levothyroxine sodium	levothyroxine sodium	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-5235	levothyroxine sodium	levothyroxine sodium	NuCar Pharmaceuticals,Inc.	NDA	Current
68071-5235	levothyroxine sodium	levothyroxine sodium	NuCar Pharmaceuticals,Inc.	NDA	Current
68788-7689	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7689	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7689	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7697	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7697	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7697	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7698	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7698	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7698	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7704	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7704	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7704	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7720	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7720	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7720	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7724	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7724	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7724	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7725	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7725	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7725	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7728	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7728	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7728	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7729	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7729	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7729	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7759	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7759	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7759	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7764	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7764	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
68788-7764	levothyroxine sodium	levothyroxine sodium	Preferred Pharmaceuticals, Inc.	NDA	Current
70518-2658	levothyroxine sodium	levothyroxine sodium	REMEDYREPACK INC.	NDA	Current
70518-2658	levothyroxine sodium	levothyroxine sodium	REMEDYREPACK INC.	NDA	Current
70518-2658	levothyroxine sodium	levothyroxine sodium	REMEDYREPACK INC.	NDA	Current
70518-2712	levothyroxine sodium	levothyroxine sodium	REMEDYREPACK INC.	NDA	Current
70518-2712	levothyroxine sodium	levothyroxine sodium	REMEDYREPACK INC.	NDA	Current
70518-2713	levothyroxine sodium	levothyroxine sodium	REMEDYREPACK INC.	NDA	Current
70518-2713	levothyroxine sodium	levothyroxine sodium	REMEDYREPACK INC.	NDA	Current
70518-2747	levothyroxine sodium	levothyroxine sodium	REMEDYREPACK INC.	NDA	Current
70518-2747	levothyroxine sodium	levothyroxine sodium	REMEDYREPACK INC.	NDA	Current
70518-2747	levothyroxine sodium	levothyroxine sodium	REMEDYREPACK INC.	NDA	Current
70934-846	levothyroxine sodium	levothyroxine sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA	Current
70934-848	levothyroxine sodium	levothyroxine sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA	Current
70934-864	levothyroxine sodium	levothyroxine sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA	Current
70934-867	levothyroxine sodium	levothyroxine sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA	Current
71205-351	levothyroxine sodium	levothyroxine sodium	Proficient Rx LP	NDA	Current
71205-352	levothyroxine sodium	levothyroxine sodium	Proficient Rx LP	NDA	Current
71205-353	levothyroxine sodium	levothyroxine sodium	Proficient Rx LP	NDA	Current
71205-354	levothyroxine sodium	levothyroxine sodium	Proficient Rx LP	NDA	Current
71205-543	levothyroxine sodium	levothyroxine sodium	Proficient Rx LP	NDA	Current
71335-1423	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
71335-1423	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
71335-1423	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
71335-1423	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
71335-1423	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
71335-1435	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
71335-1435	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
71335-1435	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
71335-1438	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
71335-1438	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
71335-1438	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
71335-1447	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
71335-1447	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
71335-1447	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76615	SUPPL	2023-11-17
76605	SUPPL	2023-11-17
74880	SUPPL	2023-07-25
70769	SUPPL	2022-04-15
69583	SUPPL	2021-12-16
58431	SUPPL	2019-04-26
58413	SUPPL	2019-04-25
49659	SUPPL	2017-09-01
49658	SUPPL	2017-09-01
26809	SUPPL	2016-05-24
4372	SUPPL	2006-03-23
36152	SUPPL	2006-03-14
21458	ORIG	2004-08-10
36151	ORIG	2002-10-24
26808	ORIG	2002-10-24