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 4 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
2019-12-13 00:20 UTC	2019-12	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016807-005	THYROLAR-0.5	0.025MG;0.0063MG	TABLET / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016807-006	THYROLAR-5	0.25MG;0.0625MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016807-001	THYROLAR-0.25	0.0125MG;0.0031MG	TABLET / ORAL	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016807-002	THYROLAR-2	0.1MG;0.025MG	TABLET / ORAL	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016807-003	THYROLAR-3	0.15MG;0.0375MG	TABLET / ORAL	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016807-004	THYROLAR-1	0.05MG;0.0125MG	TABLET / ORAL	RLD, Approved before 1982	`c0c555d07b60…`

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