Application 210632

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	SOLUTION;INTRAVENOUS	100MCG/5ML (20MCG/ML)	Yes	Yes
002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	SOLUTION;INTRAVENOUS	200MCG/5ML (40MCG/ML)	Yes	Yes
003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	SOLUTION;INTRAVENOUS	500MCG/5ML (100MCG/ML)	Yes	Yes

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	RLD / RS	Approval date
N210632-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11
N210632-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11
N210632-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N210632-001	10398669	2036-12-01	Drug product	2019-09-13
N210632-001	11135190	2036-12-01	Drug product	2021-10-07
N210632-001	12636270	2036-12-01	Drug product	2026-06-18
N210632-001	9782376	2036-12-01	Drug product	2019-06-11
N210632-002	10398669	2036-12-01	Drug product	2019-09-13
N210632-002	11135190	2036-12-01	Drug product	2021-10-07
N210632-002	12636270	2036-12-01	Drug product	2026-06-18
N210632-002	9782376	2036-12-01	Drug product	2019-06-11
N210632-003	10398669	2036-12-01	Drug product	2019-09-13
N210632-003	11135190	2036-12-01	Drug product	2021-10-07
N210632-003	12636270	2036-12-01	Drug product	2026-06-18
N210632-003	9782376	2036-12-01	Drug product	2019-06-11

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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210632-001	LEVOTHYROXINE SODIUM	100MCG/5ML (20MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210632-002	LEVOTHYROXINE SODIUM	200MCG/5ML (40MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210632-003	LEVOTHYROXINE SODIUM	500MCG/5ML (100MCG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-04-11	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 378 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N210632-001	10398669	2036-12-01	Drug product	2019-09-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210632-001	11135190	2036-12-01	Drug product	2021-10-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210632-001	12636270	2036-12-01	Drug product	2026-06-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210632-001	9782376	2036-12-01	Drug product	2019-06-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210632-002	10398669	2036-12-01	Drug product	2019-09-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210632-002	11135190	2036-12-01	Drug product	2021-10-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210632-002	12636270	2036-12-01	Drug product	2026-06-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210632-002	9782376	2036-12-01	Drug product	2019-06-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210632-003	10398669	2036-12-01	Drug product	2019-09-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210632-003	11135190	2036-12-01	Drug product	2021-10-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210632-003	12636270	2036-12-01	Drug product	2026-06-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210632-003	9782376	2036-12-01	Drug product	2019-06-11	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210632-001	10398669	2036-12-01	Drug product	2019-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-001	11135190	2036-12-01	Drug product	2021-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-001	12636270	2036-12-01	Drug product	2026-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-001	9782376	2036-12-01	Drug product	2019-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-002	10398669	2036-12-01	Drug product	2019-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-002	11135190	2036-12-01	Drug product	2021-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-002	12636270	2036-12-01	Drug product	2026-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-002	9782376	2036-12-01	Drug product	2019-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-003	10398669	2036-12-01	Drug product	2019-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-003	11135190	2036-12-01	Drug product	2021-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-003	12636270	2036-12-01	Drug product	2026-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210632-003	9782376	2036-12-01	Drug product	2019-06-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210632-001	10398669	2036-12-01	Drug product	2019-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-001	11135190	2036-12-01	Drug product	2021-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-001	12636270	2036-12-01	Drug product	2026-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-001	9782376	2036-12-01	Drug product	2019-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-002	10398669	2036-12-01	Drug product	2019-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-002	11135190	2036-12-01	Drug product	2021-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-002	12636270	2036-12-01	Drug product	2026-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-002	9782376	2036-12-01	Drug product	2019-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-003	10398669	2036-12-01	Drug product	2019-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-003	11135190	2036-12-01	Drug product	2021-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-003	12636270	2036-12-01	Drug product	2026-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210632-003	9782376	2036-12-01	Drug product	2019-06-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210632-001	10398669	2036-12-01	Drug product	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-001	11135190	2036-12-01	Drug product	2021-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-001	9782376	2036-12-01	Drug product	2019-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210632-002	10398669	2036-12-01	Drug product	2019-09-13	`011fe1cb6892…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Fresenius Kabi USA, LLC	08f4b1f8-6807-47e7-bef8-8d1972aa0557	2025-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210632 application number: NDA210632 ndc (product): 63323-885 ndc (product): 63323-895 ndc (product): 63323-890
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Fresenius Kabi USA, LLC	388a1f15-8c1c-46a5-997f-7f326f696b59	2020-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210632 application number: NDA210632 ndc (product): 63323-885
Levothyroxine Sodium	LEVOTHYROXINE SODIUM	Fresenius Kabi USA, LLC	50b1c8a4-75b6-49c8-80fc-3841ee80b183	2020-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210632 application number: NDA210632 ndc (product): 63323-885

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
63323-885	Levothyroxine Sodium	Levothyroxine Sodium	Fresenius Kabi USA, LLC	NDA	Current
63323-885	Levothyroxine Sodium	Levothyroxine Sodium	Fresenius Kabi USA, LLC	NDA	Current
63323-885	Levothyroxine Sodium	Levothyroxine Sodium	Fresenius Kabi USA, LLC	NDA	Current
63323-890	Levothyroxine Sodium	Levothyroxine Sodium	Fresenius Kabi USA, LLC	NDA	Current
63323-895	Levothyroxine Sodium	Levothyroxine Sodium	Fresenius Kabi USA, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61318	ORIG	2019-12-17
61317	ORIG	2019-12-17
58297	ORIG	2019-04-12
58296	ORIG	2019-04-12