Application 205366

Type: ANDA
Sponsor: PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	POWDER;INTRAVENOUS	200MCG/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
A205366-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS			2015-12-07

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205366-001	LEVOTHYROXINE SODIUM	200MCG/VIAL	POWDER / INTRAVENOUS	2015-12-07	`f41ea6bd6efb…`

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 11 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	2cf48978-d996-f5ba-e063-6294a90a8824	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	702016f6-8507-471f-b833-3a582aef5d2e	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	RedPharm Drug, Inc	fcb196a2-31a6-437a-e053-6294a90a98ad	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Redpharm drug	fa1bbb6e-ed15-07c9-e053-6294a90aa4a0	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Redpharm drug	fa2aebcd-3cd8-5128-e053-6294a90ac612	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Direct Rx	dd032289-acee-49fc-e053-2a95a90a5999	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	fc803107-aaa2-4753-ab97-7b4ed5cf4be5	2025-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	ddec2148-f97e-4a79-9943-4bef2386a7f2	2025-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	7ade3f9e-e3d2-401b-a6b7-aa4c9d1c9861	2025-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEVOTHYROXINE SODIUM generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Direct_rx	2b4bbe49-4bd0-ba16-e063-6394a90acefc	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Direct_Rx	2b361866-e981-567c-e063-6294a90a5a5c	2025-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals, Inc.	27e98e6d-9fd7-3a94-e063-6394a90a1dcb	2024-12-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Proficient Rx LP	576dcd01-d151-42ac-acd1-480a13bae176	2024-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	NuCare Pharmaceuticals,Inc.	29bb8dbe-f8ba-e2ba-e063-6394a90af38c	2024-12-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	a0ffe111-3574-4481-a732-b68a7d58ef71	2024-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine Sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Preferred Pharmaceuticals Inc.	a55e735f-a5b0-4b85-9fd7-3a4b6723a81b	2024-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	893f9d10-7ce5-4ae6-8f03-dfde35ca6c30	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	f23cacf6-0509-4e6b-bb59-6f1c17b16411	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Levothyroxine sodium generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodium	LEVOTHYROXINE SODIUM	Bryant Ranch Prepack	6edb9499-b869-4ec8-82d7-56d267fd3dec	2024-12-11	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.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42023-161	Levothyroxine Sodium	Levothyroxine Sodium Anhydrous	Par Pharmaceutical Companies, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
40464	ORIG	2015-12-11
10439	ORIG	2015-12-09