Application 040840

Type: ANDA
Sponsor: NORTHSTAR HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	25MG	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
A040840-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31
A040840-002	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31
A040840-003	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040840-001	AB
A040840-002	AB
A040840-003	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 4 · 123 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	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040840-002	HYDROXYZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040840-003	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040840-001	HYDROXYZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-03-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A040840-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040840-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040840-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040840-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040840-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040840-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040840-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040840-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040840-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040840-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040840-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040840-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040840-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040840-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040840-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040840-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040840-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040840-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040840-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040840-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040840-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040840-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040840-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040840-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040840-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040840-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040840-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040840-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040840-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040840-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040840-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040840-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040840-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040840-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040840-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040840-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040840-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040840-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040840-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040840-001	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	be6a2f09-c0f3-44e2-aac3-37e3702b93f0	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840 ndc (product): 50090-2614
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Redpharm Drug	4fb58637-dc30-c4dd-e063-6394a90a8bbe	2026-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Northstar RxLLC	8e5fce17-936e-46ea-a969-518c952c2091	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840 ndc (product): 16714-083 ndc (product): 16714-081 ndc (product): 16714-082
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	acc99b8f-87f0-eb3a-e053-2995a90aaaed	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840 ndc (product): 68071-2237
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	723b810b-46cc-4c45-ae1f-93ca358e007d	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	58d99cf6-2319-410b-b8be-de9c304541b6	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ffd33207-3f35-3486-e053-6394a90ac0ae	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	46266803-0905-4ae2-9d17-dbf4c2a08181	2023-09-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	3d2e63c6-993c-42b9-91a0-616246789a7b	2023-09-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	8e954579-b0f5-4ce3-bade-0b9b972f6f8b	2023-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040840 application number: ANDA040840

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-081	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	Northstar RxLLC	ANDA	Current
16714-081	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	Northstar RxLLC	ANDA	Current
16714-081	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	Northstar RxLLC	ANDA	Current
16714-081	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	Northstar RxLLC	ANDA	Current
16714-082	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	Northstar RxLLC	ANDA	Current
16714-082	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	Northstar RxLLC	ANDA	Current
16714-082	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	Northstar RxLLC	ANDA	Current
16714-082	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	Northstar RxLLC	ANDA	Current
16714-083	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	Northstar RxLLC	ANDA	Current
16714-083	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	Northstar RxLLC	ANDA	Current
16714-083	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	Northstar RxLLC	ANDA	Current
16714-083	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	Northstar RxLLC	ANDA	Current
42708-060	Hydroxyzine Hydrochloride	Hydroxyzine Hydrochloride	QPharma Inc	ANDA	Current
50090-2614	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2614	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2614	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	A-S Medication Solutions	ANDA	Current
63739-483	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-483	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-483	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-483	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-483	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	McKesson Corporation	ANDA	Current
63739-486	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-486	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-486	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-486	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-486	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	McKesson Corporation	ANDA	Current
68071-2237	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2237	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2237	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2237	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2864	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70934-191	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-191	HydrOXYzine Hydrochloride	HydrOXYzine Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current