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 2 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	fc803107-aaa2-4753-ab97-7b4ed5cf4be5	2025-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	d79526e0-d327-4545-a50c-99678766d817	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116 ndc (product): 63629-8711
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	c22af2e0-fb36-4645-a911-3d293af5bd88	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals,Inc.	a2157cf0-5c8f-7e69-e053-2a95a90aa083	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals,Inc.	a215da96-acd9-6b8d-e053-2995a90a7e0d	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	NuCar Pharmaceuticals,Inc.	a2194c58-b755-e6b5-e053-2a95a90a36d4	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	DIRECT RX	a5f15022-1166-09fe-e053-2a95a90aa218	2024-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	8849620a-5e8d-4031-884f-9a2817b050f2	2024-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	d35b5250-c26d-4d67-8a33-2f993b13e3e9	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	2daab9ce-0570-4fdf-a7bd-01c3178f8cf3	2021-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	12ccf2fd-ccf0-4bcf-8eee-e2a16c8b44d6	2020-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021116 application number: NDA021116
levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	3019762c-d480-4530-a3b2-762b523e7961	2019-11-01	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 1 of 4 · 298 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-640	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-640	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-640	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-640	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-643	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-643	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-643	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-643	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-646	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-646	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-646	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-646	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-649	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-649	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-649	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-649	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-651	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-651	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-651	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-651	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-654	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-654	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-654	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-654	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-657	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-657	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-657	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-657	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-659	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-659	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-659	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-659	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-662	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-662	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-662	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-662	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-665	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-665	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-665	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-665	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-668	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-668	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-668	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-668	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-671	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-671	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-671	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
47781-671	levothyroxine sodium	levothyroxine sodium	Alvogen, Inc.	NDA	Current
50090-4623	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4623	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4624	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4624	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4624	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4625	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4625	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4625	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4667	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4667	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4668	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4668	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4668	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4669	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4670	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4670	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4670	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4686	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4686	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4688	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4688	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4719	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4719	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4799	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4799	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4799	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-4899	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-5176	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
50090-5176	levothyroxine sodium	levothyroxine sodium	A-S Medication Solutions	NDA	Current
51655-723	levothyroxine sodium	levothyroxine sodium	Northwind Pharmaceuticals, LLC	NDA	Current
63629-8711	levothyroxine sodium	levothyroxine sodium	Bryant Ranch Prepack	NDA	Current
63629-8711	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