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 14 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	Camber Pharmaceuticals, Inc.	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	2023-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	2f129a3d-f3e6-45b2-9704-3ad171cbd8a5	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	329b6eb2-4fa3-41f6-a6ff-96d94b7a65bf	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	9d1aaa2d-c8c0-478f-8540-f92f6512cfcb	2022-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	ca197216-83f1-470a-9313-d1b923924661	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	7ceed5ff-fd41-4ebd-ade7-e31b135231c1	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	2daab9ce-0570-4fdf-a7bd-01c3178f8cf3	2021-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	2f0657d5-3e5c-4249-bfaa-7f5ef1528672	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
LEVOXYL	LEVOTHYROXINE SODIUM	Pfizer Laboratories Div Pfizer Inc	758588c3-c63e-491b-0aa2-4f50d80cb174	2020-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Fresenius Kabi USA, LLC	388a1f15-8c1c-46a5-997f-7f326f696b59	2020-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Fresenius Kabi USA, LLC	50b1c8a4-75b6-49c8-80fc-3841ee80b183	2020-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	12ccf2fd-ccf0-4bcf-8eee-e2a16c8b44d6	2020-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	97e28b00-9913-463f-9de2-08c828edbe67	2020-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	05ab038e-45fa-488e-a05e-12a2dd3564c1	2020-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	b81720f9-2836-4c1d-8691-0f6acef13316	2020-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	3019762c-d480-4530-a3b2-762b523e7961	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	434075d5-a82b-4f17-85e6-4c1922663dbc	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	18c7c63a-642e-47fe-a8ee-12aaf652b2aa	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Unithroid	LEVOTHYROXINE SODIUM	Amneal Pharmaceuticals LLC	07562e72-7eaa-4ce6-94f0-e08814787e50	2019-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEVOTHYROXINE SODIUM

Reported adverse events (FAERS/openFDA)#

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