Application 207121

Type: ANDA
Sponsor: NUVO PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	Approval date
A207121-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29
A207121-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29
A207121-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A207121-001	AB
A207121-002	AB
A207121-003	AB

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 3 · 115 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207121-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207121-003	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207121-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-03-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 115 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207121-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207121-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207121-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207121-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207121-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207121-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207121-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207121-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207121-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207121-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207121-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207121-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207121-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207121-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207121-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207121-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207121-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207121-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207121-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207121-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207121-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207121-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207121-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207121-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207121-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207121-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207121-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207121-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207121-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207121-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207121-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207121-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207121-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207121-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207121-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207121-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207121-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207121-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207121-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207121-001	AB	1	`8072bd15b7f6…`

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
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	31a907e6-7fae-0682-e063-6294a90a24a5	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207121 application number: ANDA207121
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Sunrise Pharmaceutical, Inc.	94561525-a565-4193-b64d-e1459ab05678	2024-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207121 application number: ANDA207121