Application 021924

Type: NDA
Sponsor: INSTITUT BIOCHIMIQUE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	TIROSINT	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.025MG	Yes	No
003	TIROSINT	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.05MG	Yes	No
004	TIROSINT	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.075MG	Yes	No
005	TIROSINT	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.1MG	Yes	No
006	TIROSINT	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.125MG	Yes	No
007	TIROSINT	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.15MG	Yes	No
008	TIROSINT	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.112MG	Yes	No
009	TIROSINT	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.137MG	Yes	No
010	TIROSINT	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.088MG	Yes	No
011	TIROSINT	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.175MG	Yes	No
012	TIROSINT	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.200MG	Yes	Yes
013	TIROSINT	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.013MG	Yes	No
014	TIROSINT	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.0375MG	Yes	No
015	TIROSINT	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.044MG	Yes	No
016	TIROSINT	LEVOTHYROXINE SODIUM	CAPSULE;ORAL	0.0625MG	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
N021924-002	TIROSINT	LEVOTHYROXINE SODIUM	0.025MG	CAPSULE / ORAL	RLD	2006-10-13
N021924-003	TIROSINT	LEVOTHYROXINE SODIUM	0.05MG	CAPSULE / ORAL	RLD	2006-10-13
N021924-004	TIROSINT	LEVOTHYROXINE SODIUM	0.075MG	CAPSULE / ORAL	RLD	2006-10-13
N021924-005	TIROSINT	LEVOTHYROXINE SODIUM	0.1MG	CAPSULE / ORAL	RLD	2006-10-13
N021924-006	TIROSINT	LEVOTHYROXINE SODIUM	0.125MG	CAPSULE / ORAL	RLD	2006-10-13
N021924-007	TIROSINT	LEVOTHYROXINE SODIUM	0.15MG	CAPSULE / ORAL	RLD	2006-10-13
N021924-008	TIROSINT	LEVOTHYROXINE SODIUM	0.112MG	CAPSULE / ORAL	RLD	2009-10-02
N021924-009	TIROSINT	LEVOTHYROXINE SODIUM	0.137MG	CAPSULE / ORAL	RLD	2009-10-02
N021924-010	TIROSINT	LEVOTHYROXINE SODIUM	0.088MG	CAPSULE / ORAL	RLD	2009-10-02
N021924-011	TIROSINT	LEVOTHYROXINE SODIUM	0.175MG	CAPSULE / ORAL	RLD	2017-04-25
N021924-012	TIROSINT	LEVOTHYROXINE SODIUM	0.2MG	CAPSULE / ORAL	RLD, RS	2017-04-25
N021924-013	TIROSINT	LEVOTHYROXINE SODIUM	0.013MG	CAPSULE / ORAL	RLD	2007-08-01
N021924-014	TIROSINT	LEVOTHYROXINE SODIUM	0.0375MG	CAPSULE / ORAL	RLD	2022-06-22
N021924-015	TIROSINT	LEVOTHYROXINE SODIUM	0.044MG	CAPSULE / ORAL	RLD	2022-06-22
N021924-016	TIROSINT	LEVOTHYROXINE SODIUM	0.0625MG	CAPSULE / ORAL	RLD	2022-06-22

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N021924-002	12564565	2044-09-26	Drug product	2026-03-20
N021924-003	12564565	2044-09-26	Drug product	2026-03-20
N021924-004	12564565	2044-09-26	Drug product	2026-03-20
N021924-005	12564565	2044-09-26	Drug product	2026-03-20
N021924-006	12564565	2044-09-26	Drug product	2026-03-20
N021924-007	12564565	2044-09-26	Drug product	2026-03-20
N021924-008	12564565	2044-09-26	Drug product	2026-03-20
N021924-009	12564565	2044-09-26	Drug product	2026-03-20
N021924-010	12564565	2044-09-26	Drug product	2026-03-20
N021924-011	12564565	2044-09-26	Drug product	2026-03-20
N021924-012	12564565	2044-09-26	Drug product	2026-03-20
N021924-013	12564565	2044-09-26	Drug product	2026-03-20
N021924-014	12564565	2044-09-26	Drug product	2026-03-20
N021924-015	12564565	2044-09-26	Drug product	2026-03-20
N021924-016	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 · 576 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	N021924-002	TIROSINT	0.025MG	CAPSULE / ORAL	RLD	2006-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021924-003	TIROSINT	0.05MG	CAPSULE / ORAL	RLD	2006-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021924-004	TIROSINT	0.075MG	CAPSULE / ORAL	RLD	2006-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021924-005	TIROSINT	0.1MG	CAPSULE / ORAL	RLD	2006-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021924-006	TIROSINT	0.125MG	CAPSULE / ORAL	RLD	2006-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021924-007	TIROSINT	0.15MG	CAPSULE / ORAL	RLD	2006-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021924-008	TIROSINT	0.112MG	CAPSULE / ORAL	RLD	2009-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021924-009	TIROSINT	0.137MG	CAPSULE / ORAL	RLD	2009-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021924-010	TIROSINT	0.088MG	CAPSULE / ORAL	RLD	2009-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021924-011	TIROSINT	0.175MG	CAPSULE / ORAL	RLD	2017-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021924-012	TIROSINT	0.2MG	CAPSULE / ORAL	RLD, RS	2017-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021924-013	TIROSINT	0.013MG	CAPSULE / ORAL	RLD	2007-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021924-014	TIROSINT	0.0375MG	CAPSULE / ORAL	RLD	2022-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021924-015	TIROSINT	0.044MG	CAPSULE / ORAL	RLD	2022-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021924-016	TIROSINT	0.0625MG	CAPSULE / ORAL	RLD	2022-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021924-002	TIROSINT	0.025MG	CAPSULE / ORAL	RLD	2006-10-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021924-003	TIROSINT	0.05MG	CAPSULE / ORAL	RLD	2006-10-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021924-004	TIROSINT	0.075MG	CAPSULE / ORAL	RLD	2006-10-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021924-005	TIROSINT	0.1MG	CAPSULE / ORAL	RLD	2006-10-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021924-006	TIROSINT	0.125MG	CAPSULE / ORAL	RLD	2006-10-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021924-007	TIROSINT	0.15MG	CAPSULE / ORAL	RLD	2006-10-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021924-008	TIROSINT	0.112MG	CAPSULE / ORAL	RLD	2009-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021924-009	TIROSINT	0.137MG	CAPSULE / ORAL	RLD	2009-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021924-010	TIROSINT	0.088MG	CAPSULE / ORAL	RLD	2009-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021924-011	TIROSINT	0.175MG	CAPSULE / ORAL	RLD	2017-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021924-012	TIROSINT	0.2MG	CAPSULE / ORAL	RLD, RS	2017-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021924-013	TIROSINT	0.013MG	CAPSULE / ORAL	RLD	2007-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021924-014	TIROSINT	0.0375MG	CAPSULE / ORAL	RLD	2022-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021924-015	TIROSINT	0.044MG	CAPSULE / ORAL	RLD	2022-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021924-016	TIROSINT	0.0625MG	CAPSULE / ORAL	RLD	2022-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021924-002	TIROSINT	0.025MG	CAPSULE / ORAL	RLD	2006-10-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021924-003	TIROSINT	0.05MG	CAPSULE / ORAL	RLD	2006-10-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021924-004	TIROSINT	0.075MG	CAPSULE / ORAL	RLD	2006-10-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021924-005	TIROSINT	0.1MG	CAPSULE / ORAL	RLD	2006-10-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021924-006	TIROSINT	0.125MG	CAPSULE / ORAL	RLD	2006-10-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021924-007	TIROSINT	0.15MG	CAPSULE / ORAL	RLD	2006-10-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021924-008	TIROSINT	0.112MG	CAPSULE / ORAL	RLD	2009-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021924-009	TIROSINT	0.137MG	CAPSULE / ORAL	RLD	2009-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021924-010	TIROSINT	0.088MG	CAPSULE / ORAL	RLD	2009-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021924-011	TIROSINT	0.175MG	CAPSULE / ORAL	RLD	2017-04-25	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	N021924-008	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021924-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021924-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021924-006	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021924-007	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021924-010	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021924-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021924-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021924-006	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021924-007	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021924-010	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021924-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021924-007	AB	1	`8869cabd3fbd…`
2023-05-13 08:27 UTC	2023-05	N021924-012	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021924-012	AB	1	`3bdfa0b2c4d7…`

Observed Orange Book patent history#

Patent history page 1 of 22 · 847 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-002	7691411	2024-03-14	Drug product	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-002	7723390	2024-03-14	Drug product	2010-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-003	7691411	2024-03-14	Drug product	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-003	7723390	2024-03-14	Drug product	2010-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-004	7691411	2024-03-14	Drug product	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-004	7723390	2024-03-14	Drug product	2010-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-005	7691411	2024-03-14	Drug product	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-005	7723390	2024-03-14	Drug product	2010-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-006	7691411	2024-03-14	Drug product	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-006	7723390	2024-03-14	Drug product	2010-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-007	7691411	2024-03-14	Drug product	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-007	7723390	2024-03-14	Drug product	2010-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-008	7691411	2024-03-14	Drug product	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-008	7723390	2024-03-14	Drug product	2010-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-009	7691411	2024-03-14	Drug product	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-009	7723390	2024-03-14	Drug product	2010-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-010	7691411	2024-03-14	Drug product	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-010	7723390	2024-03-14	Drug product	2010-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-011	7691411	2024-03-14	Drug product	2019-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-011	7723390	2024-03-14	Drug product	2019-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-012	7691411	2024-03-14	Drug product	2019-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-012	7723390	2024-03-14	Drug product	2019-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-013	7691411	2024-03-14	Drug product	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021924-013	7723390	2024-03-14	Drug product	2010-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021924-002	7691411	2024-03-14	Drug product	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021924-002	7723390	2024-03-14	Drug product	2010-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021924-003	7691411	2024-03-14	Drug product	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021924-003	7723390	2024-03-14	Drug product	2010-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021924-004	7691411	2024-03-14	Drug product	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021924-004	7723390	2024-03-14	Drug product	2010-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021924-005	7691411	2024-03-14	Drug product	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021924-005	7723390	2024-03-14	Drug product	2010-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021924-006	7691411	2024-03-14	Drug product	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021924-006	7723390	2024-03-14	Drug product	2010-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021924-007	7691411	2024-03-14	Drug product	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021924-007	7723390	2024-03-14	Drug product	2010-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021924-008	7691411	2024-03-14	Drug product	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021924-008	7723390	2024-03-14	Drug product	2010-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021924-009	7691411	2024-03-14	Drug product	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021924-009	7723390	2024-03-14	Drug product	2010-05-27	`2680178bc6a6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tirosint	LEVOTHYROXINE SODIUM	IBSA Pharma Inc.	7a7ade79-0165-4e31-b84e-667416c00c7e	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021924 application number: NDA021924 ndc (product): 71858-0060 ndc (product): 71858-0035 ndc (product): 71858-0050 ndc (product): 71858-0015 ndc (product): 71858-0020 ndc (product): 71858-0025 ndc (product): 71858-0045 ndc (product): 71858-0040 ndc (product): 71858-0010 ndc (product): 71858-0030 ndc (product): 71858-0055
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	YARAL Pharma Inc.	d28d7202-1278-0486-e053-2995a90af286	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021924 application number: NDA021924 ndc (product): 82347-0005 ndc (product): 82347-0015 ndc (product): 82347-0010

NDC Listings For This Application#

NDC listings for this application page 2 of 3 · 178 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71858-0010	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0010	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0010	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0010	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0015	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0015	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0015	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0015	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0015	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0015	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0015	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0020	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0020	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0020	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0020	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0020	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0020	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0020	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0025	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0025	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0025	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0025	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0025	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0025	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0025	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0030	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0030	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0030	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0030	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0030	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0030	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0030	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0035	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0035	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0035	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0035	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0035	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0035	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0035	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0040	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0040	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0040	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0040	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0040	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0040	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0040	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0045	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0045	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0045	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0045	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0045	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0045	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0045	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0050	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0050	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0050	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0050	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0050	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0050	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0050	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0055	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0055	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0055	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0055	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0055	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0055	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0055	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0060	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0060	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0060	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0060	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0060	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0060	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
71858-0060	Tirosint	levothyroxine sodium	IBSA Pharma Inc.	NDA	Current
82347-0005	Levothyroxine Sodium	levothyroxine sodium	YARAL Pharma Inc.	NDA AUTHORIZED GENERIC	Current
82347-0005	Levothyroxine Sodium	levothyroxine sodium	YARAL Pharma Inc.	NDA AUTHORIZED GENERIC	Current
82347-0010	Levothyroxine Sodium	levothyroxine sodium	YARAL Pharma Inc.	NDA AUTHORIZED GENERIC	Current
82347-0010	Levothyroxine Sodium	levothyroxine sodium	YARAL Pharma Inc.	NDA AUTHORIZED GENERIC	Current
82347-0015	Levothyroxine Sodium	levothyroxine sodium	YARAL Pharma Inc.	NDA AUTHORIZED GENERIC	Current
82347-0015	Levothyroxine Sodium	levothyroxine sodium	YARAL Pharma Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72501	SUPPL	2022-10-31
72490	SUPPL	2022-10-28
50648	SUPPL	2017-12-11
6461	SUPPL	2012-03-12
37883	SUPPL	2012-03-06
42351	ORIG	2008-09-04
6460	SUPPL	2008-01-09
16576	SUPPL	2007-12-27
6459	ORIG	2006-10-23
16575	ORIG	2006-10-18