Application 040146

Type: ANDA
Sponsor: PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	ELIXIR;ORAL	2.5MG/5ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040146-001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL		RS	1996-08-21

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040146-001	FLUPHENAZINE HYDROCHLORIDE	2.5MG/5ML	ELIXIR / ORAL	RS	1996-08-21	`e64feba35796…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	f0a89d5d-01db-47f3-a873-33ab49c6e4f8	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040146 application number: ANDA040146 ndc (product): 0121-0654

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0654	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0654	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0654	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0654	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0654	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0654	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
17856-0654	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0654	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
50090-3320	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	A-S Medication Solutions	ANDA	Current