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 5 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
2020-11-12 02:37 UTC	2020-11	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`a72a2bbeb626…`

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