Application 020105

Type: NDA
Sponsor: PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIOSTAT	LIOTHYRONINE SODIUM	INJECTABLE;INJECTION	EQ 0.01MG BASE/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020105-001	TRIOSTAT	LIOTHYRONINE SODIUM	EQ 0.01MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-12-31

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1991-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION		RLD	1991-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION		RLD	1991-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION		RLD	1991-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION		RLD	1991-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION		RLD	1991-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION		RLD	1991-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020105-001	TRIOSTAT	EQ 0.01MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-12-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020105-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020105-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020105-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020105-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020105-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020105-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020105-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020105-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020105-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020105-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020105-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020105-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020105-001	AP	1	`ea99ee380514…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020105-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020105-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020105-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020105-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020105-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020105-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020105-001	AP	1	`cb3db0bc1861…`

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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Liothyronine Sodium	LIOTHYRONINE SODIUM	Bryant Ranch Prepack	31a11006-8122-49fc-8769-a28a359ac526	2023-11-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIOTHYRONINE SODIUM
Liothyronine Sodium	LIOTHYRONINE SODIUM	Bryant Ranch Prepack	7efdd16d-37e6-4dc8-a6c5-5b42c4813379	2023-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIOTHYRONINE SODIUM
Liothyronine Sodium	LIOTHYRONINE SODIUM	Bryant Ranch Prepack	20cbf84d-80f2-4b94-ad47-6aaa362fb4d0	2023-11-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIOTHYRONINE SODIUM
liothyronine sodium	LIOTHYRONINE SODIUM	Sun Pharmaceutical Industries, Inc.	892e63ef-3a60-45fa-b12b-d6795acc0956	2023-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIOTHYRONINE SODIUM
Liothyronine Sodium	LIOTHYRONINE SODIUM	Proficient Rx LP	f882d34f-6b9f-4d9d-8a3e-3054ba91c506	2023-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIOTHYRONINE SODIUM
Liothyronine Sodium	LIOTHYRONINE SODIUM	SIGMAPHARM LABORATORIES, LLC	38ef3766-bb9a-402e-9e4a-ad8bb5b26e4c	2023-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIOTHYRONINE SODIUM
Liothyronine Sodium	LIOTHYRONINE SODIUM	Teva Pharmaceuticals USA, Inc.	548d684a-86f5-4e57-9844-d8cf0a84e068	2021-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIOTHYRONINE SODIUM

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
42023-120	Triostat	liothyronine sodium	Par Pharmaceutical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
34268	SUPPL	2002-05-20
21166	SUPPL	2002-05-20