Application 090097

Type: ANDA
Sponsor: MAYNE PHARMA INC

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
A090097-001	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2009-03-20
A090097-002	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2009-03-20
A090097-003	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2009-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090097-001	AB
A090097-002	AB
A090097-003	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 4 · 123 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	A090097-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2009-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090097-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2009-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090097-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2009-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090097-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2009-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090097-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2009-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090097-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2009-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090097-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2009-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090097-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2009-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090097-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2009-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090097-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2009-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090097-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2009-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090097-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2009-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090097-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2009-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090097-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2009-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090097-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2009-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090097-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2009-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090097-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2009-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090097-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2009-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090097-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2009-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090097-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2009-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090097-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2009-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090097-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2009-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090097-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2009-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090097-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2009-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090097-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2009-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090097-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2009-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090097-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2009-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090097-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2009-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090097-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2009-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090097-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2009-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090097-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2009-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090097-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2009-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090097-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2009-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090097-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2009-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090097-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2009-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090097-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2009-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090097-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2009-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090097-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2009-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090097-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2009-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090097-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2009-03-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A090097-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090097-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090097-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090097-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090097-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090097-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090097-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090097-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090097-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090097-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090097-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090097-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090097-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090097-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090097-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090097-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090097-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090097-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090097-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090097-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090097-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090097-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090097-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090097-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090097-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090097-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090097-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090097-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090097-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090097-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090097-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090097-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090097-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090097-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090097-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090097-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090097-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090097-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090097-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090097-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Liothyronine Sodium	LIOTHYRONINE SODIUM	Golden State Medical Supply, Inc.	ababc2ad-0458-663e-e053-2a95a90a5a86	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090097 application number: ANDA090097 ndc (product): 51407-384 ndc (product): 51407-385 ndc (product): 51407-386
Liothyronine Sodium	LIOTHYRONINE SODIUM	Dr. Reddy's Labratories Inc.	0b0f2db9-642d-d84f-b102-b43de34bbe75	2024-03-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090097 application number: ANDA090097

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0179-0238	Liothyronine Sodium	Liothyronine Sodium	KAISER FOUNDATION HOSPITA	ANDA	Current
0574-0220	Liothyronine Sodium	Liothyronine Sodium	Paddock Laboratories, LLC	ANDA	Current
0574-0222	Liothyronine Sodium	Liothyronine Sodium	Paddock Laboratories, LLC	ANDA	Current
0574-0223	Liothyronine Sodium	Liothyronine Sodium	Paddock Laboratories, LLC	ANDA	Current
33261-964	Liothyronine Sodium	Liothyronine Sodium	Aidarex Pharmaceuticals LLC	ANDA	Current
43063-252	Liothyronine Sodium	Liothyronine Sodium	PD-Rx Pharmaceuticals, In	ANDA	Current
43063-253	Liothyronine Sodium	Liothyronine Sodium	PD-Rx Pharmaceuticals, In	ANDA	Current
51407-384	Liothyronine Sodium	Liothyronine Sodium	Golden State Medical Supply	ANDA	Current
51407-384	Liothyronine Sodium	Liothyronine Sodium	Golden State Medical Supply	ANDA	Current
51407-385	Liothyronine Sodium	Liothyronine Sodium	Golden State Medical Supply	ANDA	Current
51407-385	Liothyronine Sodium	Liothyronine Sodium	Golden State Medical Supply	ANDA	Current
51407-386	Liothyronine Sodium	Liothyronine Sodium	Golden State Medical Supply	ANDA	Current
51862-320	Liothyronine Sodium	Liothyronine Sodium	Mayne Pharma	ANDA	Current
51862-320	Liothyronine Sodium	Liothyronine Sodium	Mayne Pharma	ANDA	Current
51862-321	Liothyronine Sodium	Liothyronine Sodium	Mayne Pharma	ANDA	Current
51862-321	Liothyronine Sodium	Liothyronine Sodium	Mayne Pharma	ANDA	Current
51862-322	Liothyronine Sodium	Liothyronine Sodium	Mayne Pharma	ANDA	Current
51862-322	Liothyronine Sodium	Liothyronine Sodium	Mayne Pharma	ANDA	Current
61919-239	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	DIRECT RX	ANDA	Current
61919-239	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	DIRECT RX	ANDA	Current
63629-7002	Liothyronine Sodium	Liothyronine Sodium	Bryant Ranch Prepack	ANDA	Current
68071-2133	Liothyronine Sodium	Liothyronine Sodium	NuCare Pharmaceuticals, Inc.	ANDA	Current
68151-0237	Liothyronine Sodium	Liothyronine Sodium	Carilion Materials Management	ANDA	Current
68151-0238	Liothyronine Sodium	Liothyronine Sodium	Carilion Materials Management	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22706	ORIG	2011-12-09