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 1 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	Mylan Pharmaceuticals Inc.	115a84c2-0126-4dd7-816e-1873875f1e49	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine Sodium generic name: LIOTHYRONINE SODIUM
Liothyronine Sodium	LIOTHYRONINE SODIUM	Preferred Pharmaceuticals Inc.	57744c7c-af44-4bc4-a5a8-79f05710f469	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine Sodium generic name: LIOTHYRONINE SODIUM
Cytomel	LIOTHYRONINE SODIUM	Pfizer Laboratories Div Pfizer Inc	51452b31-ff68-4e0c-b982-c15502ebf1d3	2026-05-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIOTHYRONINE SODIUM
Liothyronine Sodium	LIOTHYRONINE SODIUM	ASCLEMED USA INC.	26cf6872-f4d4-41dd-8957-a000f13efbb3	2026-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine Sodium generic name: LIOTHYRONINE SODIUM
Liomny	LIOTHYRONINE SODIUM	SIGMAPHARM LABORATORIES, LLC	0dcec611-2b7a-4cf3-80c3-7389be2f0a94	2025-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LIOTHYRONINE SODIUM
Liothyronine Sodium	LIOTHYRONINE SODIUM	PD-Rx Pharmaceuticals, Inc.	76fa4eb6-fefa-4e97-9543-f81e465743e6	2025-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine Sodium generic name: LIOTHYRONINE SODIUM
Liothyronine Sodium	LIOTHYRONINE SODIUM	Golden State Medical Supply, Inc.	ababc2ad-0458-663e-e053-2a95a90a5a86	2025-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine Sodium generic name: LIOTHYRONINE SODIUM
liothyronine sodium	LIOTHYRONINE SODIUM	A-S Medication Solutions	1d6b6f92-89e8-497a-ab23-d0afa2137d1f	2025-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: liothyronine sodium generic name: LIOTHYRONINE SODIUM
Liothyronine sodium	LIOTHYRONINE SODIUM	Bryant Ranch Prepack	b18e24fd-def0-4ff4-aa08-5f91c03c6f9e	2024-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine sodium generic name: LIOTHYRONINE SODIUM
Liothyronine sodium	LIOTHYRONINE SODIUM	Bryant Ranch Prepack	5222f13d-7222-4845-b863-49e7558f5b1a	2024-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine sodium generic name: LIOTHYRONINE SODIUM
Liothyronine sodium	LIOTHYRONINE SODIUM	Zydus Pharmaceuticals (USA) Inc.	c54cf95f-6465-4203-b98b-a54ba5a26843	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine sodium generic name: LIOTHYRONINE SODIUM
Liothyronine sodium	LIOTHYRONINE SODIUM	Northstar Rx LLC	c97dc9ec-af73-4836-aa0d-c27e66e792a9	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine sodium generic name: LIOTHYRONINE SODIUM
Liothyronine sodium	LIOTHYRONINE SODIUM	Bryant Ranch Prepack	9d3633e3-44b7-4f62-9fe4-e5c7c4129345	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine sodium generic name: LIOTHYRONINE SODIUM
Liothyronine sodium	LIOTHYRONINE SODIUM	Biocon Pharma Inc.	21002702-422b-1402-73b8-670314d8e579	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine sodium generic name: LIOTHYRONINE SODIUM
Liothyronine Sodium	LIOTHYRONINE SODIUM	Dr. Reddy's Labratories Inc.	0b0f2db9-642d-d84f-b102-b43de34bbe75	2024-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine Sodium generic name: LIOTHYRONINE SODIUM
Liothyronine Sodium	LIOTHYRONINE SODIUM	NuCare Pharmaceuticals,Inc.	1133ebe8-38c2-2505-e063-6294a90aaa2f	2024-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine Sodium generic name: LIOTHYRONINE SODIUM
Liothyronine Sodium	LIOTHYRONINE SODIUM	A-S Medication Solutions	db65bcd8-e9c9-4095-9975-03be1f443823	2024-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine Sodium generic name: LIOTHYRONINE SODIUM
Liothyronine sodium	LIOTHYRONINE SODIUM	Zydus Lifesciences Limited	4fb09346-3d30-4a7c-a97c-480d5924997a	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine sodium generic name: LIOTHYRONINE SODIUM
Liothyronine sodium	LIOTHYRONINE SODIUM	A-S Medication Solutions	52baac91-4b00-40d4-9ca7-8b9405bd415c	2023-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Liothyronine sodium generic name: LIOTHYRONINE SODIUM
Liothyronine Sodium	LIOTHYRONINE SODIUM	XGen Pharmaceuticals DJB, Inc.	a8b39730-de19-497d-bde8-6594aa528403	2023-12-01	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.