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FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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HYDROCHLORIDE	INJECTABLE;INJECTION	2.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982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PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N011751-003	PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N011751-004	PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982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PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	2.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	Approved before 1982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 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	c2c6d6a1-b4b9-506d-e053-2995a90aac23	2025-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	AvPAK	e3277017-1d58-7105-e053-2995a90a9255	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	AvPAK	dbfd138a-e107-3f78-e053-2995a90a6d8c	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Zameer Pharmaceuticals LLC	d9db3882-a7b5-435b-9d5a-a5e4ef7c2537	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	d0a090fa-f7c9-4f6d-a9a3-9838870c7049	2024-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	c4448579-3ccb-442e-8950-a219d1f01a98	2024-11-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Zydus Lifesciences Limited	977dc369-6b6d-4ad1-9239-a46f63a764bd	2024-11-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Dr. Reddys Laboratories Inc.	98aeddfd-4f24-4d1a-820d-d0abc1733794	2024-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	1991be2c-9629-4c3e-93f0-e40bcffc82b0	2024-11-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Aurobindo Pharma Limited	e73764e7-e666-4ad3-a029-04a528dc1c9e	2024-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Lannett Company, Inc.	6cd6ba35-3481-48c1-87db-dc74ce9d7d75	2024-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	d571f04f-6190-42f2-932c-5a075fd978b9	2024-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	83ce71b9-28eb-4074-b1e7-192ed254c529	2024-09-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	7c29fb1f-9403-4e55-abd9-36adfb152e8e	2024-07-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Proficient Rx LP	bc22941e-d2e7-4165-91ea-7239c8b9882d	2023-02-01	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.