Application 211415

Type: NDA
Sponsor: JDP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUZYTTIR	CETIRIZINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	10MG/ML (10MG/ML)	Yes	Yes

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
N211415-001	QUZYTTIR	CETIRIZINE HYDROCHLORIDE	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-10-04

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N211415-001	8513259	2030-02-11	U-2636	2019-10-30
N211415-001	9119771	2030-02-11	U-2635	2019-10-30
N211415-001	9180090	2030-02-11	U-2635	2019-10-30
N211415-001	8263581	2030-02-28	U-2635	2019-10-30
N211415-001	8314083	2030-02-28	U-2634	2019-10-30

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 1 of 2 · 41 observed 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	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211415-001	QUZYTTIR	10MG/ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-10-04	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211415-001	8513259	2030-02-11	U-2636	2019-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211415-001	9119771	2030-02-11	U-2635	2019-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211415-001	9180090	2030-02-11	U-2635	2019-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211415-001	8263581	2030-02-28	U-2635	2019-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211415-001	8314083	2030-02-28	U-2634	2019-10-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211415-001	8513259	2030-02-11	U-2636	2019-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211415-001	9119771	2030-02-11	U-2635	2019-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211415-001	9180090	2030-02-11	U-2635	2019-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211415-001	8263581	2030-02-28	U-2635	2019-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211415-001	8314083	2030-02-28	U-2634	2019-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211415-001	8513259	2030-02-11	U-2636	2019-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211415-001	9119771	2030-02-11	U-2635	2019-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211415-001	9180090	2030-02-11	U-2635	2019-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211415-001	8263581	2030-02-28	U-2635	2019-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211415-001	8314083	2030-02-28	U-2634	2019-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211415-001	8513259	2030-02-11	U-2636	2019-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211415-001	9119771	2030-02-11	U-2635	2019-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211415-001	9180090	2030-02-11	U-2635	2019-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211415-001	8263581	2030-02-28	U-2635	2019-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211415-001	8314083	2030-02-28	U-2634	2019-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211415-001	8513259	2030-02-11	U-2636	2019-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211415-001	9119771	2030-02-11	U-2635	2019-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211415-001	9180090	2030-02-11	U-2635	2019-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211415-001	8263581	2030-02-28	U-2635	2019-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211415-001	8314083	2030-02-28	U-2634	2019-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211415-001	8513259	2030-02-11	U-2636	2019-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211415-001	9119771	2030-02-11	U-2635	2019-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211415-001	9180090	2030-02-11	U-2635	2019-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211415-001	8263581	2030-02-28	U-2635	2019-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211415-001	8314083	2030-02-28	U-2634	2019-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211415-001	8513259	2030-02-11	U-2636	2019-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211415-001	9119771	2030-02-11	U-2635	2019-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211415-001	9180090	2030-02-11	U-2635	2019-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211415-001	8263581	2030-02-28	U-2635	2019-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211415-001	8314083	2030-02-28	U-2634	2019-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211415-001	8513259	2030-02-11	U-2636	2019-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211415-001	9119771	2030-02-11	U-2635	2019-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211415-001	9180090	2030-02-11	U-2635	2019-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211415-001	8263581	2030-02-28	U-2635	2019-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211415-001	8314083	2030-02-28	U-2634	2019-10-30	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211415-001	NP	2022-10-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211415-001	NP	2022-10-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211415-001	NP	2022-10-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211415-001	NP	2022-10-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211415-001	NP	2022-10-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211415-001	NP	2022-10-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211415-001	NP	2022-10-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211415-001	NP	2022-10-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211415-001	NP	2022-10-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211415-001	NP	2022-10-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211415-001	NP	2022-10-04	`3f01610625f2…`
2023-01-26 05:58 UTC	2023-01	N211415-001	NP	2022-10-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211415-001	NP	2022-10-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211415-001	NP	2022-10-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211415-001	NP	2022-10-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211415-001	NP	2022-10-04	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUZYTTIR	CETIRIZINE HYDROCHLORIDE	ESTEVE PHARMACEUTICALS, S.A.	573770f6-b76e-f6ba-e063-6294a90aa54d	2026-08-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211415 application number: NDA211415
QUZYTTIR	CETIRIZINE HYDROCHLORIDE	TerSera Therapeutics LLC	f33e859d-ebc9-4d4f-a57d-204c48760d20	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211415 application number: NDA211415 ndc (product): 70720-100

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70720-100	QUZYTTIR	Cetirizine Hydrochloride	TerSera Therapeutics LLC	NDA	Current
70720-100	QUZYTTIR	Cetirizine Hydrochloride	TerSera Therapeutics LLC	NDA	Current
70720-100	QUZYTTIR	Cetirizine Hydrochloride	TerSera Therapeutics LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82981	SUPPL	2025-07-29
82967	SUPPL	2025-07-29
62456	ORIG	2020-04-06
61089	SUPPL	2019-11-29
60264	ORIG	2019-10-07
60255	ORIG	2019-10-07
62903	ORIG	1900-01-01