Application 011751

Type: NDA
Sponsor: APOTHECON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	INJECTABLE;INJECTION	2.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N011751-001	PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N011751-002	PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N011751-003	PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N011751-004	PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N011751-005	PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	2.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	Approved before 1982

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 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N011751-001	PROLIXIN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011751-002	PROLIXIN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011751-003	PROLIXIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011751-004	PROLIXIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N011751-005	PROLIXIN	2.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N011751-001	PROLIXIN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011751-002	PROLIXIN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011751-003	PROLIXIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011751-004	PROLIXIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N011751-005	PROLIXIN	2.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N011751-001	PROLIXIN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011751-002	PROLIXIN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011751-003	PROLIXIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011751-004	PROLIXIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011751-005	PROLIXIN	2.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011751-001	PROLIXIN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011751-002	PROLIXIN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011751-003	PROLIXIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011751-004	PROLIXIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011751-005	PROLIXIN	2.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011751-001	PROLIXIN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011751-002	PROLIXIN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011751-003	PROLIXIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011751-004	PROLIXIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011751-005	PROLIXIN	2.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011751-001	PROLIXIN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011751-002	PROLIXIN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011751-003	PROLIXIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011751-004	PROLIXIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011751-005	PROLIXIN	2.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011751-001	PROLIXIN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011751-002	PROLIXIN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011751-003	PROLIXIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011751-004	PROLIXIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011751-005	PROLIXIN	2.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011751-001	PROLIXIN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011751-002	PROLIXIN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011751-003	PROLIXIN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011751-004	PROLIXIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011751-005	PROLIXIN	2.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`

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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 generic name: FLUPHENAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.