Application 214047

Type: NDA
Sponsor: REGULIANCE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THYQUIDITY	LEVOTHYROXINE SODIUM	SOLUTION; ORAL	100MCG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214047-001	THYQUIDITY	LEVOTHYROXINE SODIUM	100MCG/5ML	SOLUTION / ORAL		RLD, RS	2020-11-30

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214047-001	9050307	2031-08-06		Drug product	2020-12-14

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214047-001	THYQUIDITY	100MCG/5ML	SOLUTION / ORAL	RLD, RS	2020-11-30	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214047-001	9050307	2031-08-06	Drug product	2020-12-14	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THYQUIDITY	LEVOTHYROXINE SODIUM	Oliva Therapeutics, LLC	0c839877-50e4-455f-9b6c-462efb09cb96	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 214047 application number: NDA214047

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66689-105	THYQUIDITY	Levothyroxine Sodium	VistaPharm, Inc.	NDA	Current
66689-105	THYQUIDITY	Levothyroxine Sodium	VistaPharm, Inc.	NDA	Current
66689-105	THYQUIDITY	Levothyroxine Sodium	VistaPharm, Inc.	NDA	Current
81116-100	THYQUIDITY	Levothyroxine Sodium	GALENICA S.A.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68013	ORIG	2021-07-06
65497	ORIG	2020-12-04
65441	ORIG	2020-12-01