Application 074795

Type: ANDA
Sponsor: TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUPHENAZINE DECANOATE	FLUPHENAZINE DECANOATE	INJECTABLE;INJECTION	25MG/ML	No	No

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

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
A074795-001	FLUPHENAZINE DECANOATE	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION			1996-09-10

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 · 43 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	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074795-001	FLUPHENAZINE DECANOATE	25MG/ML	INJECTABLE / INJECTION	1996-09-10	`f41ea6bd6efb…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluphenazine Decanoate	FLUPHENAZINE DECANOATE	Par Health USA, LLC	970e6fde-9cc8-475b-8a9e-bde0579a72a7	2026-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Decanoate generic name: FLUPHENAZINE DECANOATE
Fluphenazine Decanoate	FLUPHENAZINE DECANOATE	Par Health USA, LLC	b580471f-44a1-4da0-96ad-2f537eabec3e	2026-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Decanoate generic name: FLUPHENAZINE DECANOATE
Fluphenazine Decanoate	FLUPHENAZINE DECANOATE	Sagent Pharmaceuticals	1842a678-c32b-4e81-998e-597fc370fb9e	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Decanoate generic name: FLUPHENAZINE DECANOATE
Fluphenazine Decanoate	FLUPHENAZINE DECANOATE	Bryant Ranch Prepack	044f49f3-f980-4ef8-8beb-78412702cd9d	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Decanoate generic name: FLUPHENAZINE DECANOATE
FLUPHENAZINE DECANOATE	FLUPHENAZINE DECANOATE	Eugia US LLC	1f532edc-1a2c-4221-80dd-1ac158dd3a72	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FLUPHENAZINE DECANOATE generic name: FLUPHENAZINE DECANOATE
Fluphenazine Decanoate	FLUPHENAZINE DECANOATE	Novadoz Pharmaceuticals LLC	8d7ba627-cf3f-4b94-aee8-8b44cc9400be	2025-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Decanoate generic name: FLUPHENAZINE DECANOATE
Fluphenazine Decanoate	FLUPHENAZINE DECANOATE	Hikma Pharmaceuticals USA Inc.	1967dc24-f2a5-4095-baa9-a9d1c5410311	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Decanoate generic name: FLUPHENAZINE DECANOATE
fluphenazine decanoate	FLUPHENAZINE DECANOATE	Gland Pharma Limited	8caa3896-cde1-4cb1-9332-2e92bcf5c1f6	2024-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: fluphenazine decanoate generic name: FLUPHENAZINE DECANOATE
Fluphenazine Decanoate	FLUPHENAZINE DECANOATE	Mylan Institutional LLC	3832d3d3-15ce-4d41-8431-11e9bd04cf4d	2024-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Decanoate generic name: FLUPHENAZINE DECANOATE
Fluphenazine Decanoate	FLUPHENAZINE DECANOATE	Fresenius Kabi USA, LLC	f8ba014e-aea0-49bc-8345-4e0a384b484e	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: Fluphenazine Decanoate generic name: FLUPHENAZINE DECANOATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42879	ORIG	2011-05-06