Application 074725

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	CONCENTRATE;ORAL	5MG/ML	No	Yes

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

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
A074725-001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL		RS	1996-09-16

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074725-001	FLUPHENAZINE HYDROCHLORIDE	5MG/ML	CONCENTRATE / ORAL	RS	1996-09-16	`cb3db0bc1861…`

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	0860b3f3-3116-40f8-bcb0-e5c47731bdc8	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074725 application number: ANDA074725 ndc (product): 0121-0653

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0653	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
0121-0653	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Pharmaceutical Associates, Inc.	ANDA	Current
70518-3553	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22353	ORIG	2011-05-06