Application 214803

Type: ANDA
Sponsor: ZYDUS

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 1.

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	TE codes	Approval date
A214803-001	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22
A214803-002	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22
A214803-003	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A214803-001	AB
A214803-002	AB
A214803-003	AB

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 3 · 105 observed 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
2026-02-19 14:30 UTC	2026-02	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214803-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2021-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214803-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2021-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214803-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2021-01-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214803-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214803-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214803-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214803-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214803-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214803-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214803-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214803-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214803-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214803-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214803-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214803-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214803-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214803-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214803-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214803-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214803-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214803-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214803-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214803-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214803-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214803-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214803-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214803-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214803-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214803-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214803-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214803-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214803-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214803-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214803-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214803-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214803-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214803-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214803-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214803-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214803-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214803-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214803-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214803-001	AB	1	`8072bd15b7f6…`

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 1 · 7 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	b18e24fd-def0-4ff4-aa08-5f91c03c6f9e	2024-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214803 application number: ANDA214803 ndc (product): 71335-2001
Liothyronine sodium	LIOTHYRONINE SODIUM	Bryant Ranch Prepack	5222f13d-7222-4845-b863-49e7558f5b1a	2024-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214803 application number: ANDA214803 ndc (product): 71335-1943
Liothyronine sodium	LIOTHYRONINE SODIUM	Zydus Pharmaceuticals (USA) Inc.	c54cf95f-6465-4203-b98b-a54ba5a26843	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214803 application number: ANDA214803 ndc (product): 68382-584 ndc (product): 68382-582 ndc (product): 68382-583
Liothyronine sodium	LIOTHYRONINE SODIUM	Northstar Rx LLC	c97dc9ec-af73-4836-aa0d-c27e66e792a9	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214803 application number: ANDA214803 ndc (product): 16714-168 ndc (product): 16714-166 ndc (product): 16714-167
Liothyronine sodium	LIOTHYRONINE SODIUM	Bryant Ranch Prepack	9d3633e3-44b7-4f62-9fe4-e5c7c4129345	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214803 application number: ANDA214803 ndc (product): 71335-1978
Liothyronine sodium	LIOTHYRONINE SODIUM	Zydus Lifesciences Limited	4fb09346-3d30-4a7c-a97c-480d5924997a	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214803 application number: ANDA214803 ndc (product): 70771-1607 ndc (product): 70771-1608 ndc (product): 70771-1606
Liothyronine sodium	LIOTHYRONINE SODIUM	A-S Medication Solutions	52baac91-4b00-40d4-9ca7-8b9405bd415c	2023-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214803 application number: ANDA214803 ndc (product): 50090-5586

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-166	Liothyronine sodium	Liothyronine sodium	Northstar Rx LLC	ANDA	Current
16714-167	Liothyronine sodium	Liothyronine sodium	Northstar Rx LLC	ANDA	Current
16714-168	Liothyronine sodium	Liothyronine sodium	Northstar Rx LLC	ANDA	Current
50090-5586	Liothyronine sodium	Liothyronine sodium	A-S Medication Solutions	ANDA	Current
50090-5586	Liothyronine sodium	Liothyronine sodium	A-S Medication Solutions	ANDA	Current
68382-582	Liothyronine sodium	Liothyronine sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-583	Liothyronine sodium	Liothyronine sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-584	Liothyronine sodium	Liothyronine sodium	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1606	Liothyronine sodium	Liothyronine sodium	Cadila Healthcare Limited	ANDA	Current
70771-1607	Liothyronine sodium	Liothyronine sodium	Cadila Healthcare Limited	ANDA	Current
70771-1608	Liothyronine sodium	Liothyronine sodium	Cadila Healthcare Limited	ANDA	Current
71335-1943	Liothyronine sodium	Liothyronine sodium	Bryant Ranch Prepack	ANDA	Current
71335-1978	Liothyronine sodium	Liothyronine sodium	Bryant Ranch Prepack	ANDA	Current
71335-1978	Liothyronine sodium	Liothyronine sodium	Bryant Ranch Prepack	ANDA	Current
71335-2001	Liothyronine sodium	Liothyronine sodium	Bryant Ranch Prepack	ANDA	Current
71335-2001	Liothyronine sodium	Liothyronine sodium	Bryant Ranch Prepack	ANDA	Current