Application 070533

Type: ANDA
Sponsor: APOTHECON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	CONCENTRATE;ORAL	5MG/ML	No	No

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

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
A070533-001	PROLIXIN	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL			1985-11-07

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070533-001	PROLIXIN	5MG/ML	CONCENTRATE / ORAL	1985-11-07	`f41ea6bd6efb…`

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.