Application 089743

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	Yes
002	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	1MG	No	No
003	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	2.5MG	No	No
004	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	5MG	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	RLD / RS	Approval date
A089743-001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25
A089743-002	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25
A089743-003	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25
A089743-004	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089743-001	AB
A089743-002	AB
A089743-003	AB
A089743-004	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089743-001	FLUPHENAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		1988-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089743-002	FLUPHENAZINE HYDROCHLORIDE	1MG	TABLET / ORAL	AB		1988-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089743-003	FLUPHENAZINE HYDROCHLORIDE	2.5MG	TABLET / ORAL	AB		1988-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089743-004	FLUPHENAZINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	RS	1988-08-25	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A089743-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089743-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089743-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089743-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089743-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089743-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089743-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089743-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089743-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089743-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089743-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089743-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089743-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089743-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089743-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089743-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089743-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089743-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089743-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089743-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089743-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089743-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089743-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089743-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089743-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089743-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089743-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089743-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089743-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089743-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089743-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089743-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089743-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089743-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089743-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089743-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089743-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089743-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089743-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A089743-004	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	Major Pharmaceuticals	e8d4065a-45fc-4adf-9406-2122ca131d99	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089743 application number: ANDA089743 ndc (product): 0904-7159 ndc (product): 0904-7158 ndc (product): 0904-7160 ndc (product): 0904-7157
Fluphenazine Hydrochloride	FLUPHENAZINE HYDROCHLORIDE	Lannett Company, Inc.	6cd6ba35-3481-48c1-87db-dc74ce9d7d75	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089743 application number: ANDA089743 ndc (product): 0527-1789 ndc (product): 0527-1788 ndc (product): 0527-1791 ndc (product): 0527-1790

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1788	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1788	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1788	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1789	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1789	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1789	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1790	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1790	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1790	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1791	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1791	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1791	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1791	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1791	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Lannett Company, Inc.	ANDA	Current
0904-7157	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7158	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7159	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7160	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	Major Pharmaceuticals	ANDA	Current
42291-435	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	AvKARE	ANDA	Current
42291-435	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	AvKARE	ANDA	Current
42291-436	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	AvKARE	ANDA	Current
42291-436	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	AvKARE	ANDA	Current
42291-437	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	AvKARE	ANDA	Current
42291-437	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	AvKARE	ANDA	Current
42291-438	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	AvKARE	ANDA	Current
42291-438	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	AvKARE	ANDA	Current
50090-4740	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4740	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5758	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	A-S Medication Solutions	ANDA	Current
68084-950	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	American Health Packaging	ANDA	Current
68084-950	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	American Health Packaging	ANDA	Current
68084-950	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	American Health Packaging	ANDA	Current
70518-0318	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0318	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0318	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0318	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0318	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0318	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0318	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2583	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2583	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2583	Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	REMEDYREPACK INC.	ANDA	Current