Application 091382

Type: ANDA
Sponsor: SUN PHARM

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
A091382-001	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2016-04-20
A091382-002	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2016-04-20
A091382-003	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2016-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091382-001	AB
A091382-002	AB
A091382-003	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	A091382-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2016-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091382-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2016-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091382-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2016-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091382-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2016-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091382-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2016-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091382-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2016-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091382-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2016-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091382-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2016-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091382-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2016-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091382-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2016-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091382-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2016-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091382-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2016-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091382-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2016-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091382-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2016-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091382-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2016-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091382-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2016-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091382-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2016-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091382-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2016-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091382-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2016-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091382-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2016-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091382-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2016-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091382-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2016-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091382-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2016-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091382-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2016-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091382-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2016-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091382-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2016-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091382-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2016-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091382-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2016-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091382-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2016-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091382-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2016-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091382-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2016-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091382-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2016-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091382-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2016-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091382-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2016-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091382-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2016-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091382-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2016-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091382-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2016-04-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091382-002	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	2016-04-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091382-003	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	2016-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091382-001	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	2016-04-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A091382-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091382-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091382-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091382-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091382-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091382-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091382-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091382-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091382-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091382-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091382-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091382-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091382-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091382-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091382-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091382-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091382-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091382-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091382-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091382-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091382-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091382-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091382-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091382-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091382-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091382-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091382-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091382-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091382-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091382-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091382-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091382-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091382-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091382-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091382-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091382-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091382-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091382-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091382-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091382-001	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	A-S Medication Solutions	1d6b6f92-89e8-497a-ab23-d0afa2137d1f	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091382 application number: ANDA091382
liothyronine sodium	LIOTHYRONINE SODIUM	Sun Pharmaceutical Industries, Inc.	892e63ef-3a60-45fa-b12b-d6795acc0956	2023-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091382 application number: ANDA091382 ndc (product): 62756-590 ndc (product): 62756-589 ndc (product): 62756-591

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60687-625	liothyronine sodium	liothyronine sodium	American Health Packaging	ANDA	Current
62756-589	liothyronine sodium	liothyronine sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-589	liothyronine sodium	liothyronine sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-590	liothyronine sodium	liothyronine sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-590	liothyronine sodium	liothyronine sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-591	liothyronine sodium	liothyronine sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-591	liothyronine sodium	liothyronine sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63629-8337	liothyronine sodium	liothyronine sodium	Bryant Ranch Prepack	ANDA	Current
63629-8337	liothyronine sodium	liothyronine sodium	Bryant Ranch Prepack	ANDA	Current
63629-8337	liothyronine sodium	liothyronine sodium	Bryant Ranch Prepack	ANDA	Current
71335-1671	liothyronine sodium	liothyronine sodium	Bryant Ranch Prepack	ANDA	Current
71335-1671	liothyronine sodium	liothyronine sodium	Bryant Ranch Prepack	ANDA	Current
71335-1671	liothyronine sodium	liothyronine sodium	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31526	ORIG	2016-04-22