Application 090326

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	TABLET;ORAL	EQ 0.005MG BASE	No	No
002	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	TABLET;ORAL	EQ 0.025MG BASE	No	No
003	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	TABLET;ORAL	EQ 0.05MG BASE	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	Approval date
A090326-001	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	2009-07-14
A090326-002	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	2009-07-14
A090326-003	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	2009-07-14

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090326-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	2009-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090326-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	2009-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090326-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	2009-07-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090326-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	2009-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090326-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	2009-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090326-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	2009-07-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090326-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	2009-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090326-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	2009-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090326-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	2009-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090326-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	2009-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090326-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	2009-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090326-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	2009-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090326-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	2009-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090326-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	2009-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090326-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	2009-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090326-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	2009-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090326-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	2009-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090326-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	2009-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090326-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	2009-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090326-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	2009-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090326-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	2009-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090326-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	2009-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090326-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	2009-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090326-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	2009-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090326-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	2009-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090326-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	2009-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090326-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	2009-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090326-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	2009-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090326-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	2009-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090326-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	2009-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090326-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	2009-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090326-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	2009-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090326-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	2009-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090326-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	2009-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090326-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	2009-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090326-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	2009-07-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090326-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	2009-07-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090326-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	2009-07-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090326-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	2009-07-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090326-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	2009-07-14	`301d65b070ca…`

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 brand name: Liothyronine Sodium 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 brand name: Liothyronine Sodium 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 brand name: Liothyronine Sodium 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 brand name: liothyronine sodium 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 brand name: Liothyronine Sodium 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 brand name: Liothyronine Sodium generic name: LIOTHYRONINE SODIUM
Liothyronine Sodium	LIOTHYRONINE SODIUM	Teva Pharmaceuticals USA, Inc.	548d684a-86f5-4e57-9844-d8cf0a84e068	2020-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine Sodium generic name: LIOTHYRONINE SODIUM

Reported adverse events (FAERS/openFDA)#

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