Application 087294

Type: ANDA
Sponsor: WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	SYRUP;ORAL	10MG/5ML	No	Yes

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

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
A087294-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087294-001	AA

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	1982-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	1982-04-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	1982-04-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	1982-04-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	1982-04-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	1982-04-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	1982-04-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	1982-04-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087294-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RLD, RS	1982-04-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A087294-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087294-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087294-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087294-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087294-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087294-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087294-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087294-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087294-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087294-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087294-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087294-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087294-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087294-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087294-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087294-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087294-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087294-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087294-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087294-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087294-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087294-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087294-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087294-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087294-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087294-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087294-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087294-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087294-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087294-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087294-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087294-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087294-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087294-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087294-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087294-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087294-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087294-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087294-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087294-001	AA	1	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	0de7a377-7a8f-4119-b172-1eadb4b7e1be	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087294 application number: ANDA087294
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Chartwell RX, LLC	53b2d731-f38a-47c0-9e5c-abd3b45e2fe1	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087294 application number: ANDA087294
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	bcddc5ce-6cfb-4a09-8e6c-c956b65e3188	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087294 application number: ANDA087294 ndc (product): 63187-494

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-4822	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
17856-0150	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Atlantic Biologicals Corps	ANDA	Current
17856-0150	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0150	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Atlantic Biologicals Corps	ANDA	Current
50090-0276	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	A-S Medication Solutions	ANDA	Current
60432-150	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Morton Grove Pharmaceuticals, Inc.	ANDA	Current
63187-494	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-494	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-494	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Proficient Rx LP	ANDA	Current
63629-1855	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68151-0150	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	Carilion Materials Management	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73375	SUPPL	2023-02-02
73374	SUPPL	2023-02-02
39593	SUPPL	2014-06-24
31431	SUPPL	2014-06-11