Application 010379

Type: NDA
Sponsor: KING PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYTOMEL	LIOTHYRONINE SODIUM	TABLET;ORAL	EQ 0.005MG BASE	Yes	No
002	CYTOMEL	LIOTHYRONINE SODIUM	TABLET;ORAL	EQ 0.025MG BASE	Yes	No
003	CYTOMEL	LIOTHYRONINE SODIUM	TABLET;ORAL	EQ 0.05MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS
N010379-001	CYTOMEL	LIOTHYRONINE SODIUM	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982
N010379-002	CYTOMEL	LIOTHYRONINE SODIUM	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982
N010379-003	CYTOMEL	LIOTHYRONINE SODIUM	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N010379-001	AB
N010379-002	AB
N010379-003	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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N010379-003	CYTOMEL	EQ 0.05MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N010379-001	CYTOMEL	EQ 0.005MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N010379-002	CYTOMEL	EQ 0.025MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N010379-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N010379-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N010379-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N010379-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N010379-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N010379-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N010379-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N010379-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N010379-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N010379-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010379-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010379-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010379-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010379-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010379-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N010379-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010379-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010379-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010379-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010379-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010379-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010379-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010379-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010379-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010379-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010379-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010379-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010379-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010379-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010379-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010379-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010379-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010379-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010379-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010379-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010379-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N010379-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N010379-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N010379-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010379-001	AB	1	`79d66fd596c7…`

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	Mylan Pharmaceuticals Inc.	115a84c2-0126-4dd7-816e-1873875f1e49	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 010379 application number: NDA010379 ndc (product): 59762-1207 ndc (product): 59762-1206 ndc (product): 59762-1208
Cytomel	LIOTHYRONINE SODIUM	Pfizer Laboratories Div Pfizer Inc	51452b31-ff68-4e0c-b982-c15502ebf1d3	2026-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 010379 application number: NDA010379 ndc (product): 60793-116 ndc (product): 60793-115 ndc (product): 60793-117

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-0413	Cytomel	liothyronine sodium	A-S Medication Solutions	NDA	Current
59762-1206	Liothyronine Sodium	liothyronine sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1206	Liothyronine Sodium	liothyronine sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1206	Liothyronine Sodium	liothyronine sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1206	Liothyronine Sodium	liothyronine sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1207	Liothyronine Sodium	liothyronine sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1207	Liothyronine Sodium	liothyronine sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1207	Liothyronine Sodium	liothyronine sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1207	Liothyronine Sodium	liothyronine sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1208	Liothyronine Sodium	liothyronine sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1208	Liothyronine Sodium	liothyronine sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1208	Liothyronine Sodium	liothyronine sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1208	Liothyronine Sodium	liothyronine sodium	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
60793-115	Cytomel	liothyronine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-115	Cytomel	liothyronine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-115	Cytomel	liothyronine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-116	Cytomel	liothyronine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-116	Cytomel	liothyronine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-116	Cytomel	liothyronine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-117	Cytomel	liothyronine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-117	Cytomel	liothyronine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current
60793-117	Cytomel	liothyronine sodium	Pfizer Laboratories Div Pfizer Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61576	SUPPL	2020-01-15
57070	SUPPL	2018-12-31
57014	SUPPL	2018-12-26
33015	SUPPL	2002-05-17
11898	SUPPL	2002-05-17
217	SUPPL	2001-09-13