Application 208749

Type: ANDA
Sponsor: MAIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	POWDER;INTRAVENOUS	100MCG/VIAL	No	No
002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	POWDER;INTRAVENOUS	200MCG/VIAL	No	No
003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	POWDER;INTRAVENOUS	500MCG/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208749-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21
A208749-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21
A208749-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A208749-001	AP
A208749-002	AP
A208749-003	AP

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208749-002	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208749-003	LEVOTHYROXINE SODIUM	500MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208749-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2018-12-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208749-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208749-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208749-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208749-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208749-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208749-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208749-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208749-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208749-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208749-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208749-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208749-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208749-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208749-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208749-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208749-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208749-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208749-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208749-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208749-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208749-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208749-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208749-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208749-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208749-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208749-003	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208749-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208749-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208749-003	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208749-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208749-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208749-003	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208749-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208749-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208749-003	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208749-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208749-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208749-003	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208749-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A208749-002	AP	1	`3f01610625f2…`

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
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Sagent Pharmaceuticals	f57e9b19-6f17-4520-80fc-511322cc56c9	2023-10-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208749 application number: ANDA208749

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 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70511-111	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	MAIA Pharmaceuticals, Inc.	ANDA	Current
70511-112	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	MAIA Pharmaceuticals, Inc.	ANDA	Current
70511-113	Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	MAIA Pharmaceuticals, Inc.	ANDA	Current
70860-451	Levothyroxine Sodium	levothyroxine sodium anhydrous	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-452	Levothyroxine Sodium	levothyroxine sodium anhydrous	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-453	Levothyroxine Sodium	levothyroxine sodium anhydrous	Athenex Pharmaceutical Division, LLC.	ANDA	Current