Application 016807

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THYROLAR-0.25	LIOTRIX (T4;T3)	TABLET;ORAL	0.0125MG;0.0031MG	Yes	No
002	THYROLAR-2	LIOTRIX (T4;T3)	TABLET;ORAL	0.1MG;0.025MG	Yes	No
003	THYROLAR-3	LIOTRIX (T4;T3)	TABLET;ORAL	0.15MG;0.0375MG	Yes	No
004	THYROLAR-1	LIOTRIX (T4;T3)	TABLET;ORAL	0.05MG;0.0125MG	Yes	No
005	THYROLAR-0.5	LIOTRIX (T4;T3)	TABLET;ORAL	0.025MG;0.0063MG	Yes	No
006	THYROLAR-5	LIOTRIX (T4;T3)	TABLET;ORAL	0.25MG;0.0625MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N016807-001	THYROLAR-0.25	LIOTRIX (T4;T3)	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982
N016807-002	THYROLAR-2	LIOTRIX (T4;T3)	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982
N016807-003	THYROLAR-3	LIOTRIX (T4;T3)	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982
N016807-004	THYROLAR-1	LIOTRIX (T4;T3)	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982
N016807-005	THYROLAR-0.5	LIOTRIX (T4;T3)	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982
N016807-006	THYROLAR-5	LIOTRIX (T4;T3)	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982

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 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0456-0040	Thyrolar	liothyronine sodium, LEVOTHYROXINE SODIUM	Allergan, Inc.	NDA	Current
0456-0045	Thyrolar	liothyronine sodium, LEVOTHYROXINE SODIUM	Allergan, Inc.	NDA	Current
0456-0050	Thyrolar	liothyronine sodium, LEVOTHYROXINE SODIUM	Allergan, Inc.	NDA	Current
0456-0055	Thyrolar	liothyronine sodium, LEVOTHYROXINE SODIUM	Allergan, Inc.	NDA	Current
0456-0060	Thyrolar	liothyronine sodium, LEVOTHYROXINE SODIUM	Allergan, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
13037	SUPPL	2002-10-01