Application 089586

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	1MG	No	No
003	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	2.5MG	No	No
004	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A089586-001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	1987-10-16
A089586-002	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	1987-10-16
A089586-003	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	1987-10-16
A089586-004	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	1987-10-16

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089586-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	1987-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089586-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	1987-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089586-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	1987-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089586-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	1987-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089586-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	1987-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089586-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	1987-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089586-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	1987-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089586-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	1987-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089586-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	1987-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089586-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	1987-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089586-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	1987-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089586-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	1987-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089586-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	1987-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089586-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	1987-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089586-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	1987-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089586-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	1987-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089586-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	1987-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089586-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	1987-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089586-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	1987-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089586-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	1987-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089586-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	1987-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089586-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	1987-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089586-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	1987-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089586-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	1987-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089586-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	1987-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089586-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	1987-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089586-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	1987-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089586-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	1987-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089586-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	1987-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089586-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	1987-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089586-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	1987-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089586-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	1987-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089586-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	1987-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089586-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	1987-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089586-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	1987-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089586-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	1987-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089586-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	1987-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089586-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	1987-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089586-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	1987-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089586-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	1987-10-16	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A089586-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A089586-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A089586-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A089586-004	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A089586-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A089586-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A089586-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A089586-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089586-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A089586-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A089586-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A089586-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089586-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A089586-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A089586-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A089586-004	AB	1	`ea99ee380514…`

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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluphenazine Hydrochoride	FLUPHENAZINE HYDROCHLORIDE	REMEDYREPACK INC.	91b85b8d-4c10-4395-915e-272b81ef3b12	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUPHENAZINE HYDROCHLORIDE
fluphenazine hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Coupler LLC	53864ae1-046e-f6de-e063-6294a90a13af	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: fluphenazine hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	REMEDYREPACK INC.	34395a69-d3d1-4295-8d57-ae92e2cdd992	2026-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine hydrochloride	FLUPHENAZINE HYDROCHLORIDE	REMEDYREPACK INC.	85720b55-3419-4e2c-95dd-22eec035d6f1	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE
fluphenazine hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	5b443b30-5682-4cf3-9ed0-716efddbc865	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: fluphenazine hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	7036f7c6-0792-400d-a1c7-54f21b2bd481	2026-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	4c3eea71-a7a1-4eda-9871-034ddeb83ed6	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE
fluphenazine hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Chartwell RX, LLC	325af2a4-2280-4236-8cf8-44f5700ba73f	2025-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: fluphenazine hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	4dd61338-8e4b-41c6-99d8-811a8e990c4e	2025-11-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	c69f07b1-660c-db03-e053-2995a90a5464	2025-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FLUPHENAZINE HYDROCHLORIDE generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Ajanta Pharma USA Inc.	47695e20-9c0b-4a6b-ab1a-1dfaa75e96d8	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochoride	FLUPHENAZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	9fd44ab9-79bb-472e-8434-c3d786b42de5	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Major Pharmaceuticals	e8d4065a-45fc-4adf-9406-2122ca131d99	2025-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Upsher-Smith Laboratories,LLC	f07bb3f1-c68c-441b-9de4-99a219f2500a	2025-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Coupler LLC	37c9712b-95a1-fcc4-e063-6394a90aca50	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	American Health Packaging	b6eadd59-a7d0-400e-ba1d-795b9243f77d	2025-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Coupler LLC	325c8c34-2858-af36-e063-6394a90a7814	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	f0a89d5d-01db-47f3-a873-33ab49c6e4f8	2025-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	6218cbd2-1f7f-40fa-92d2-5d5b0d7fa60b	2025-01-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	0860b3f3-3116-40f8-bcb0-e5c47731bdc8	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Hydrochloride generic name: FLUPHENAZINE HYDROCHLORIDE

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
0781-1436	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Sandoz Inc	ANDA	Current
0781-1437	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Sandoz Inc	ANDA	Current
0781-1438	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Sandoz Inc	ANDA	Current
0781-1439	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Sandoz Inc	ANDA	Current
64725-1438	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	TYA Pharmaceuticals	ANDA	Current