Application 040153

Type: ANDA
Sponsor: INVATECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	TABLET;ORAL	EQ 1MG BASE	No	No
002	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	TABLET;ORAL	EQ 2MG BASE	No	No
003	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	TABLET;ORAL	EQ 5MG BASE	No	No
004	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	TABLET;ORAL	EQ 10MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A040153-001	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	1996-10-25
A040153-002	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	1996-10-25
A040153-003	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	1996-10-25
A040153-004	TRIFLUOPERAZINE HYDROCHLORIDE	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	1996-10-25

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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040153-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	1996-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040153-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	1996-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040153-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	1996-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040153-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	1996-10-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040153-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	1996-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040153-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	1996-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040153-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	1996-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040153-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	1996-10-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040153-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	1996-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040153-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	1996-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040153-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	1996-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040153-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	1996-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040153-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	1996-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040153-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	1996-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040153-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	1996-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040153-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	1996-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040153-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	1996-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040153-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	1996-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040153-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	1996-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040153-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	1996-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040153-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	1996-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040153-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	1996-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040153-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	1996-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040153-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	1996-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040153-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	1996-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040153-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	1996-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040153-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	1996-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040153-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	1996-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040153-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	1996-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040153-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	1996-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040153-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	1996-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040153-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	1996-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040153-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	1996-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040153-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	1996-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040153-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	1996-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040153-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	1996-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040153-001	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	1996-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040153-002	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	1996-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040153-003	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	1996-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040153-004	TRIFLUOPERAZINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	1996-10-25	`5bbf6a4d5a75…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	REMEDYREPACK INC.	f789e8f4-7ed2-4cac-b1b1-5068690cd0ed	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	Safecor Health LLC	8501543b-0c74-4087-9946-e7198400814a	2026-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	REMEDYREPACK INC.	339ceb53-3b1c-459f-84eb-77bd4315c998	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	REMEDYREPACK INC.	6a05900b-ca43-483a-a460-8ac378653f12	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	Mylan Institutional Inc.	f742a579-411a-4140-91c4-edc735d638fa	2025-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	c2575a86-19e5-44df-8603-ff066bb9c9c5	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	Sandoz Inc.	ae43c10e-cfa9-4298-8af5-7a3e6524bbda	2024-11-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	Bryant Ranch Prepack	e63617bb-8186-43d3-9d01-aa53217343e4	2024-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	Bryant Ranch Prepack	19b76401-6790-44f7-b756-b078948bbf12	2024-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	Bryant Ranch Prepack	7be0a6fa-a2a0-4f9d-94ca-47ab51de9c1d	2024-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE
Trifluoperazine Hydrochloride	TRIFLUOPERAZINE HYDROCHLORIDE	Bryant Ranch Prepack	df3e0bef-1032-405d-bd18-f65c27af94eb	2024-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Trifluoperazine Hydrochloride generic name: TRIFLUOPERAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.