Application 214674

Type: ANDA
Sponsor: NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	1MG	No	No
002	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	2.5MG	No	No
003	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
004	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214674-001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-03-01
A214674-002	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-03-01
A214674-003	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-03-01
A214674-004	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A214674-001	AB
A214674-002	AB
A214674-003	AB
A214674-004	AB

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 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214674-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214674-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214674-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214674-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214674-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214674-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214674-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214674-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214674-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214674-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214674-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214674-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214674-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214674-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214674-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214674-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214674-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214674-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214674-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214674-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214674-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214674-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214674-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214674-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214674-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214674-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214674-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214674-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214674-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214674-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214674-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214674-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214674-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214674-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214674-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214674-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214674-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2021-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214674-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2021-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214674-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2021-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214674-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-03-01	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214674-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214674-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214674-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214674-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214674-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214674-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214674-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214674-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214674-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214674-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214674-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214674-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214674-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214674-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214674-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214674-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214674-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214674-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214674-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214674-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214674-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214674-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214674-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214674-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214674-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214674-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214674-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214674-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214674-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214674-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214674-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214674-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214674-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214674-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214674-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214674-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214674-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214674-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214674-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214674-004	AB	1	`d06236e962d9…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	c69f07b1-660c-db03-e053-2995a90a5464	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214674 application number: ANDA214674 ndc (product): 10135-728 ndc (product): 10135-727 ndc (product): 10135-726 ndc (product): 10135-725
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	6218cbd2-1f7f-40fa-92d2-5d5b0d7fa60b	2025-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214674 application number: ANDA214674 ndc (product): 70954-273 ndc (product): 70954-276 ndc (product): 70954-274 ndc (product): 70954-275

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-725	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-726	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-727	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-728	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	ANDA	Current
70518-3095	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3098	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70954-273	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Novitium Pharma LLC	ANDA	Current
70954-274	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Novitium Pharma LLC	ANDA	Current
70954-275	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Novitium Pharma LLC	ANDA	Current
70954-276	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Novitium Pharma LLC	ANDA	Current