Application 213647

Type: ANDA
Sponsor: AMNEAL

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
A213647-001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09
A213647-002	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09
A213647-003	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09
A213647-004	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213647-001	AB
A213647-002	AB
A213647-003	AB
A213647-004	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 · 148 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	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213647-001	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB	2020-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213647-002	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB	2020-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213647-003	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213647-004	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-09	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 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	A213647-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213647-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213647-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213647-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213647-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213647-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213647-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213647-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213647-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213647-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213647-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213647-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213647-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213647-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213647-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213647-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213647-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213647-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213647-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213647-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213647-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213647-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213647-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213647-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213647-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213647-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213647-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213647-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213647-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213647-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213647-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213647-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213647-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213647-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213647-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213647-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213647-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213647-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213647-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213647-004	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	Coupler LLC	53864ae1-046e-f6de-e063-6294a90a13af	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213647 application number: ANDA213647
fluphenazine hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	5b443b30-5682-4cf3-9ed0-716efddbc865	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213647 application number: ANDA213647 ndc (product): 69238-1681 ndc (product): 69238-1680 ndc (product): 69238-1678 ndc (product): 69238-1679

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-002	fluphenazine hydrochloride	fluphenazine hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-002	fluphenazine hydrochloride	fluphenazine hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-003	fluphenazine hydrochloride	fluphenazine hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-003	fluphenazine hydrochloride	fluphenazine hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-004	fluphenazine hydrochloride	fluphenazine hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-004	fluphenazine hydrochloride	fluphenazine hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-005	fluphenazine hydrochloride	fluphenazine hydrochloride	NorthStar Rx LLC	ANDA	Current
16714-005	fluphenazine hydrochloride	fluphenazine hydrochloride	NorthStar Rx LLC	ANDA	Current
60219-1678	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1678	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1678	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1679	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1679	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1679	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1680	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1680	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1680	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1681	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1681	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1681	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1678	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1678	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1679	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1679	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1680	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1680	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1681	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1681	fluphenazine hydrochloride	fluphenazine hydrochloride	Amneal Pharmaceuticals NY LLC	ANDA	Current
70518-3003	fluphenazine hydrochloride	fluphenazine hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3008	fluphenazine hydrochloride	fluphenazine hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3569	fluphenazine hydrochloride	fluphenazine hydrochloride	REMEDYREPACK INC.	ANDA	Current