Application 208837

Type: ANDA
Sponsor: DR REDDYS

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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208837-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS			2020-03-27

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.

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	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2020-03-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2020-03-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS	AP	2020-03-27	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208837-001	LEVOTHYROXINE SODIUM	100MCG/VIAL	POWDER / INTRAVENOUS		2020-03-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-03-12 10:30 UTC	2021-03	A208837-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208837-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208837-001	AP	1	`c0c555d07b60…`

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 10 of 14 · 279 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	American Health Packaging	38af4e36-b26b-485d-a6f3-7fbcf6072a0f	2025-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	f0680426-3581-400c-8ab5-5e6f18d0cabc	2025-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	b4654497-c986-4792-9b6b-0a791c7c205b	2025-06-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	0e0ad9f1-1f52-48ce-a996-79ebe7ad53cd	2025-06-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	247f4d1d-6e65-4f81-a377-4dd88ae16dbb	2025-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	A-S Medication Solutions	70dddaf0-f495-495f-95de-36e9efa2e373	2025-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	91afb351-f067-49a2-bdf0-336ea209718d	2025-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	237cc591-c40b-416f-ac00-96cd61bc59dc	2025-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	faaa1123-7515-46c2-abbb-b0615540c8cf	2025-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	7f8ec438-8ddf-45d2-be94-ac032e192229	2025-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fosun Pharma USA Inc.	3361138a-6e6f-e8df-e063-6294a90af2de	2025-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	ENDO USA, Inc.	9d815416-11c9-470e-a82f-89b0bf232e12	2025-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	f5fc0f34-744c-4e03-ae9f-e017e4033139	2025-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	Fresenius Kabi USA, LLC	ce990712-49c1-4f66-9ee4-c770e8ec394c	2025-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	65b266af-72a5-4409-ab55-bd14341135aa	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	A-S Medication Solutions	9ff5ad8e-f28c-4322-be6e-072487878c12	2025-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	30ccec8b-3f95-61c7-e063-6394a90a05a0	2025-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Lupin Pharmaceuticals, Inc.	18717e58-89fb-4e2f-93b6-d6ac3e988d37	2025-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Fresenius Kabi USA, LLC	08f4b1f8-6807-47e7-bef8-8d1972aa0557	2025-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	f0a63075-631d-43bf-9d8e-df79faf0a278	2025-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.