Application 089804

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
002FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDETABLET;ORAL1MGNoNo
003FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDETABLET;ORAL2.5MGNoNo
004FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDETABLET;ORAL5MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089804-001FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1988-08-12
A089804-002FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1988-08-12
A089804-003FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1988-08-12
A089804-004FLUPHENAZINE HYDROCHLORIDEFLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1988-08-12

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A089804-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1988-08-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089804-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1988-08-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089804-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1988-08-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A089804-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1988-08-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089804-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1988-08-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089804-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1988-08-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089804-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1988-08-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089804-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1988-08-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A089804-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1988-08-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089804-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1988-08-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089804-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1988-08-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A089804-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1988-08-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089804-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1988-08-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089804-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1988-08-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089804-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1988-08-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089804-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1988-08-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089804-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1988-08-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089804-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1988-08-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089804-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1988-08-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089804-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1988-08-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089804-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1988-08-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089804-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1988-08-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089804-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1988-08-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089804-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1988-08-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089804-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1988-08-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089804-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1988-08-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089804-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1988-08-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089804-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1988-08-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089804-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1988-08-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089804-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1988-08-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089804-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1988-08-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089804-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1988-08-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089804-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1988-08-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089804-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1988-08-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089804-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1988-08-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089804-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1988-08-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089804-001FLUPHENAZINE HYDROCHLORIDE10MGTABLET / ORAL1988-08-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A089804-002FLUPHENAZINE HYDROCHLORIDE1MGTABLET / ORAL1988-08-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A089804-003FLUPHENAZINE HYDROCHLORIDE2.5MGTABLET / ORAL1988-08-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A089804-004FLUPHENAZINE HYDROCHLORIDE5MGTABLET / ORAL1988-08-12d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A089804-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A089804-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A089804-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A089804-004AB174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A089804-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A089804-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A089804-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A089804-004AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089804-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A089804-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A089804-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A089804-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A089804-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A089804-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A089804-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A089804-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089804-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A089804-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A089804-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A089804-004AB1ea99ee380514…
2023-05-13 08:27 UTC2023-05A089804-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A089804-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A089804-003AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A089804-004AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A089804-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A089804-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A089804-003AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A089804-004AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089804-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089804-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089804-003AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089804-004AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089804-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A089804-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A089804-003AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A089804-004AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089804-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A089804-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A089804-003AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A089804-004AB1e64feba35796…

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 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEGolden State Medical Supply, Inc.c2c6d6a1-b4b9-506d-e053-2995a90aac232025-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEAvPAKe3277017-1d58-7105-e053-2995a90a92552025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEAvPAKdbfd138a-e107-3f78-e053-2995a90a6d8c2025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEZameer Pharmaceuticals LLCd9db3882-a7b5-435b-9d5a-a5e4ef7c25372024-12-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEUpsher-Smith Laboratories, LLCd0a090fa-f7c9-4f6d-a9a3-9838870c70492024-12-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.c4448579-3ccb-442e-8950-a219d1f01a982024-11-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEZydus Lifesciences Limited977dc369-6b6d-4ad1-9239-a46f63a764bd2024-11-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEDr. Reddys Laboratories Inc.98aeddfd-4f24-4d1a-820d-d0abc17337942024-11-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.1991be2c-9629-4c3e-93f0-e40bcffc82b02024-11-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEAurobindo Pharma Limitede73764e7-e666-4ad3-a029-04a528dc1c9e2024-11-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDELannett Company, Inc.6cd6ba35-3481-48c1-87db-dc74ce9d7d752024-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEFresenius Kabi USA, LLCd571f04f-6190-42f2-932c-5a075fd978b92024-10-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDENovadoz Pharmaceuticals LLC83ce71b9-28eb-4074-b1e7-192ed254c5292024-09-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEAlembic Pharmaceuticals Limited7c29fb1f-9403-4e55-abd9-36adfb152e8e2024-07-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE
Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEProficient Rx LPbc22941e-d2e7-4165-91ea-7239c8b9882d2023-02-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluphenazine Hydrochloride
generic name: FLUPHENAZINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6004Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6004Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6009Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6009Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6074Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6074Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6097Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6097Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0615-1501Fluphenazine HydrochlorideFluphenazine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-3574Fluphenazine HydrochlorideFluphenazine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
51079-485Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-485Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-485Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-486Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-486Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-486Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-487Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-487Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-487Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-488Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-488Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-488Fluphenazine hydrochlorideFluphenazine hydrochlorideMylan Institutional Inc.ANDACurrent
53808-0247Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
53808-0600Fluphenazine HydrochlorideFLUPHENAZINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
70518-0457Fluphenazine hydrochlorideFluphenazine hydrochlorideREMEDYREPACK INC.ANDACurrent