Application 206977

Type: NDA
Sponsor: INSTITUT BIOCHIMIQUE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	13MCG/ML	Yes	No
002	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	25MCG/ML	Yes	No
003	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	50MCG/ML	Yes	No
004	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	75MCG/ML	Yes	No
005	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	88MCG/ML	Yes	No
006	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	100MCG/ML	Yes	No
007	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	112MCG/ML	Yes	No
008	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	125MCG/ML	Yes	No
009	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	137MCG/ML	Yes	No
010	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	150MCG/ML	Yes	No
011	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	175MCG/ML	Yes	No
012	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	200MCG/ML	Yes	Yes
013	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	37.5MCG/ML	Yes	No
014	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	44MCG/ML	Yes	No
015	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	62.5MCG/ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 15 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N206977-001	TIROSINT-SOL	LEVOTHYROXINE SODIUM	13MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-002	TIROSINT-SOL	LEVOTHYROXINE SODIUM	25MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-003	TIROSINT-SOL	LEVOTHYROXINE SODIUM	50MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-004	TIROSINT-SOL	LEVOTHYROXINE SODIUM	75MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-005	TIROSINT-SOL	LEVOTHYROXINE SODIUM	88MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-006	TIROSINT-SOL	LEVOTHYROXINE SODIUM	100MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-007	TIROSINT-SOL	LEVOTHYROXINE SODIUM	112MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-008	TIROSINT-SOL	LEVOTHYROXINE SODIUM	125MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-009	TIROSINT-SOL	LEVOTHYROXINE SODIUM	137MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-010	TIROSINT-SOL	LEVOTHYROXINE SODIUM	150MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-011	TIROSINT-SOL	LEVOTHYROXINE SODIUM	175MCG/ML	SOLUTION / ORAL	RLD	2016-12-15
N206977-012	TIROSINT-SOL	LEVOTHYROXINE SODIUM	200MCG/ML	SOLUTION / ORAL	RLD, RS	2016-12-15
N206977-013	TIROSINT-SOL	LEVOTHYROXINE SODIUM	37.5MCG/ML	SOLUTION / ORAL	RLD	2021-01-13
N206977-014	TIROSINT-SOL	LEVOTHYROXINE SODIUM	44MCG/ML	SOLUTION / ORAL	RLD	2021-01-13
N206977-015	TIROSINT-SOL	LEVOTHYROXINE SODIUM	62.5MCG/ML	SOLUTION / ORAL	RLD	2021-01-13

Orange Book patents#

Current patent rows page 1 of 1 · 75 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206977-001	10537538	2037-02-28		Drug product	2020-02-19
N206977-001	11096913	2037-02-28		Drug product	2021-09-20
N206977-001	11241382	2039-09-17	U-3757		2023-12-14
N206977-001	11241382	2039-09-17	U-3758		2023-12-14
N206977-001	12564565	2044-09-26		Drug product	2026-03-20
N206977-002	10537538	2037-02-28		Drug product	2020-02-19
N206977-002	11096913	2037-02-28		Drug product	2021-09-20
N206977-002	11241382	2039-09-17	U-3757		2023-12-14
N206977-002	11241382	2039-09-17	U-3758		2023-12-14
N206977-002	12564565	2044-09-26		Drug product	2026-03-20
N206977-003	10537538	2037-02-28		Drug product	2020-02-19
N206977-003	11096913	2037-02-28		Drug product	2021-09-20
N206977-003	11241382	2039-09-17	U-3757		2023-12-14
N206977-003	11241382	2039-09-17	U-3758		2023-12-14
N206977-003	12564565	2044-09-26		Drug product	2026-03-20
N206977-004	10537538	2037-02-28		Drug product	2020-02-19
N206977-004	11096913	2037-02-28		Drug product	2021-09-20
N206977-004	11241382	2039-09-17	U-3757		2023-12-14
N206977-004	11241382	2039-09-17	U-3758		2023-12-14
N206977-004	12564565	2044-09-26		Drug product	2026-03-20
N206977-005	10537538	2037-02-28		Drug product	2020-02-19
N206977-005	11096913	2037-02-28		Drug product	2021-09-20
N206977-005	11241382	2039-09-17	U-3757		2023-12-14
N206977-005	11241382	2039-09-17	U-3758		2023-12-14
N206977-005	12564565	2044-09-26		Drug product	2026-03-20
N206977-006	10537538	2037-02-28		Drug product	2020-02-19
N206977-006	11096913	2037-02-28		Drug product	2021-09-20
N206977-006	11241382	2039-09-17	U-3757		2023-12-14
N206977-006	11241382	2039-09-17	U-3758		2023-12-14
N206977-006	12564565	2044-09-26		Drug product	2026-03-20
N206977-007	10537538	2037-02-28		Drug product	2020-02-19
N206977-007	11096913	2037-02-28		Drug product	2021-09-20
N206977-007	11241382	2039-09-17	U-3757		2023-12-14
N206977-007	11241382	2039-09-17	U-3758		2023-12-14
N206977-007	12564565	2044-09-26		Drug product	2026-03-20
N206977-008	10537538	2037-02-28		Drug product	2020-02-19
N206977-008	11096913	2037-02-28		Drug product	2021-09-20
N206977-008	11241382	2039-09-17	U-3757		2023-12-14
N206977-008	11241382	2039-09-17	U-3758		2023-12-14
N206977-008	12564565	2044-09-26		Drug product	2026-03-20
N206977-009	10537538	2037-02-28		Drug product	2020-02-19
N206977-009	11096913	2037-02-28		Drug product	2021-09-20
N206977-009	11241382	2039-09-17	U-3757		2023-12-14
N206977-009	11241382	2039-09-17	U-3758		2023-12-14
N206977-009	12564565	2044-09-26		Drug product	2026-03-20
N206977-010	10537538	2037-02-28		Drug product	2020-02-19
N206977-010	11096913	2037-02-28		Drug product	2021-09-20
N206977-010	11241382	2039-09-17	U-3757		2023-12-14
N206977-010	11241382	2039-09-17	U-3758		2023-12-14
N206977-010	12564565	2044-09-26		Drug product	2026-03-20
N206977-011	10537538	2037-02-28		Drug product	2020-02-19
N206977-011	11096913	2037-02-28		Drug product	2021-09-20
N206977-011	11241382	2039-09-17	U-3757		2023-12-14
N206977-011	11241382	2039-09-17	U-3758		2023-12-14
N206977-011	12564565	2044-09-26		Drug product	2026-03-20
N206977-012	10537538	2037-02-28		Drug product	2020-02-19
N206977-012	11096913	2037-02-28		Drug product	2021-09-20
N206977-012	11241382	2039-09-17	U-3757		2023-12-14
N206977-012	11241382	2039-09-17	U-3758		2023-12-14
N206977-012	12564565	2044-09-26		Drug product	2026-03-20
N206977-013	10537538	2037-02-28		Drug product	2022-04-20
N206977-013	11096913	2037-02-28		Drug product	2021-09-20
N206977-013	11241382	2039-09-17	U-3757		2023-12-14
N206977-013	11241382	2039-09-17	U-3758		2023-12-14
N206977-013	12564565	2044-09-26		Drug product	2026-03-20
N206977-014	10537538	2037-02-28		Drug product	2022-04-20
N206977-014	11096913	2037-02-28		Drug product	2021-09-20
N206977-014	11241382	2039-09-17	U-3757		2023-12-14
N206977-014	11241382	2039-09-17	U-3758		2023-12-14
N206977-014	12564565	2044-09-26		Drug product	2026-03-20
N206977-015	10537538	2037-02-28		Drug product	2022-04-20
N206977-015	11096913	2037-02-28		Drug product	2021-09-20
N206977-015	11241382	2039-09-17	U-3757		2023-12-14
N206977-015	11241382	2039-09-17	U-3758		2023-12-14
N206977-015	12564565	2044-09-26		Drug product	2026-03-20

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 15 · 597 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206977-001	TIROSINT-SOL	13MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-002	TIROSINT-SOL	25MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-003	TIROSINT-SOL	50MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-004	TIROSINT-SOL	75MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-005	TIROSINT-SOL	88MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-006	TIROSINT-SOL	100MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-007	TIROSINT-SOL	112MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-008	TIROSINT-SOL	125MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-009	TIROSINT-SOL	137MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-010	TIROSINT-SOL	150MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-011	TIROSINT-SOL	175MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-012	TIROSINT-SOL	200MCG/ML	SOLUTION / ORAL	RLD, RS	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-013	TIROSINT-SOL	37.5MCG/ML	SOLUTION / ORAL	RLD	2021-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-014	TIROSINT-SOL	44MCG/ML	SOLUTION / ORAL	RLD	2021-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-015	TIROSINT-SOL	62.5MCG/ML	SOLUTION / ORAL	RLD	2021-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-001	TIROSINT-SOL	13MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-002	TIROSINT-SOL	25MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-003	TIROSINT-SOL	50MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-004	TIROSINT-SOL	75MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-005	TIROSINT-SOL	88MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-006	TIROSINT-SOL	100MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-007	TIROSINT-SOL	112MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-008	TIROSINT-SOL	125MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-009	TIROSINT-SOL	137MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-010	TIROSINT-SOL	150MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-011	TIROSINT-SOL	175MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-012	TIROSINT-SOL	200MCG/ML	SOLUTION / ORAL	RLD, RS	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-013	TIROSINT-SOL	37.5MCG/ML	SOLUTION / ORAL	RLD	2021-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-014	TIROSINT-SOL	44MCG/ML	SOLUTION / ORAL	RLD	2021-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206977-015	TIROSINT-SOL	62.5MCG/ML	SOLUTION / ORAL	RLD	2021-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206977-001	TIROSINT-SOL	13MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-002	TIROSINT-SOL	25MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-003	TIROSINT-SOL	50MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-004	TIROSINT-SOL	75MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-005	TIROSINT-SOL	88MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-006	TIROSINT-SOL	100MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-007	TIROSINT-SOL	112MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-008	TIROSINT-SOL	125MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-009	TIROSINT-SOL	137MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206977-010	TIROSINT-SOL	150MCG/ML	SOLUTION / ORAL	RLD	2016-12-15	`6a471c1ec25d…`

Observed Orange Book patent history#

Patent history page 1 of 39 · 1,551 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206977-001	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-001	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-001	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-001	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-002	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-002	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-002	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-002	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-003	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-003	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-003	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-003	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-004	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-004	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-004	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-004	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-005	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-005	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-005	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-005	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-006	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-006	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-006	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-006	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-007	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-007	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-007	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-007	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-008	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-008	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-008	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-008	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-009	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-009	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-009	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-009	11241382	2039-09-17	U-3757		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-010	10537538	2037-02-28		Drug product	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-010	11096913	2037-02-28		Drug product	2021-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-010	11241382	2039-09-17	U-3758		2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206977-010	11241382	2039-09-17	U-3757		2023-12-14	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tirosint SOL	LEVOTHYROXINE SODIUM	IBSA Pharma Inc.	5d378add-f13d-40f2-99dc-0f2340ab44b7	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 206977 application number: NDA206977 ndc (product): 71858-0120 ndc (product): 71858-0110 ndc (product): 71858-0130 ndc (product): 71858-0115 ndc (product): 71858-0105 ndc (product): 71858-0113 ndc (product): 71858-0112 ndc (product): 71858-0125 ndc (product): 71858-0117

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 150 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0112	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0112	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0112	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0112	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0112	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0112	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0113	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0113	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0113	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0113	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0113	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0113	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0117	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0117	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0117	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0117	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0117	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0117	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0130	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0130	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0130	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0130	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0130	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0130	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0130	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76622	SUPPL	2023-11-17
76621	SUPPL	2023-11-17
76597	SUPPL	2023-11-17
76596	SUPPL	2023-11-17
72957	SUPPL	2022-12-20
72952	SUPPL	2022-12-20
48851	ORIG	2017-06-28
47429	SUPPL	2017-03-02
47368	SUPPL	2017-02-28
46423	ORIG	2016-12-21
46215	ORIG	2016-12-19
51311	ORIG	1900-01-01
51310	ORIG	1900-01-01
51309	ORIG	1900-01-01