FDA.reportPublic FDA data

Application 075341

Type
ANDA
Sponsor
AAIPHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETOCONAZOLEKETOCONAZOLETABLET;ORAL200MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075341-001KETOCONAZOLEKETOCONAZOLE200MGTABLET / ORAL1999-07-27

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A075341-001KETOCONAZOLE200MGTABLET / ORAL1999-07-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075341-001KETOCONAZOLE200MGTABLET / ORAL1999-07-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075341-001KETOCONAZOLE200MGTABLET / ORAL1999-07-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075341-001KETOCONAZOLE200MGTABLET / ORAL1999-07-27a50c72e98297…

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 4 · 65 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTI-DANDRUFFKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.5ac93feb-eb6d-7563-e063-6294a90ad2e02026-09-05WarningsName fallback
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLE CREAM, 2%REMEDYREPACK INC.ea56cddf-94c9-46b6-8791-995b741cfbd72026-09-01Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
KetoconClear CreamKETOCONAZOLEGuangzhou Shunfei Network Technology Co., Ltd.5a54eebe-5b4a-28dd-e063-6294a90a607f2026-08-31WarningsName fallback
generic name: KETOCONAZOLE
Gembooxt Ketoconazole 1% Medicated ShampoosKETOCONAZOLEGuangdong Quadrant Ecological Technology Co., Ltd.49965e91-43c3-65d7-e063-6294a90abaec2026-08-27WarningsName fallback
generic name: KETOCONAZOLE
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.599f2cce-0c27-d425-e063-6394a90a15652026-08-22WarningsName fallback
generic name: KETOCONAZOLE
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.59a0a062-92d1-210a-e063-6394a90a9bf92026-08-22WarningsName fallback
generic name: KETOCONAZOLE
KETOCONAZOLEKETOCONAZOLEAmerisyn LLC1d598696-c6f3-4b7c-ad73-949d2089df352026-08-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: KETOCONAZOLE
generic name: KETOCONAZOLE
KETOCONAZOLEKETOCONAZOLEPD-Rx Pharmaceuticals, Inc.f162e616-21b4-49b1-b437-15e21001a6f02026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: KETOCONAZOLE
generic name: KETOCONAZOLE
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.4cfe234c-49c0-18e8-e063-6294a90a0b1d2026-07-02WarningsName fallback
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLENuCare Pharmaceuticals, Inc.53492ad1-baca-a7f6-e063-6294a90a29902026-06-02Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEPreferred Pharmaceuticals Inc.d59df5bf-bfa6-45fa-81f6-8c8ee2f24cf82026-05-14Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLE CREAM, 2%Preferred Pharmaceuticals Inc.abc2446c-cdc2-48fe-80f2-cf0038d2a85e2026-05-14Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
KetoconazoleKETOCONAZOLEANI Pharmaceuticals, Inc.00c1cac8-a865-4583-aaba-3a0f21fb31e62026-01-29Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
ketoconazoleKETOCONAZOLEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLCcad7c647-34a9-4e4e-83b3-8d78e58f588f2026-01-28Warnings, Adverse reactionsName fallback
brand name: ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLENORTHSTAR RX LLCbf3e48fd-e063-42e6-acd1-580ddc6e93be2026-01-26Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLE CREAM, 2%ASCLEMED USA INC.6f1a5365-99df-4169-9382-14c2643e561d2026-01-23Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
KetoconazoleKETOCONAZOLE CREAM, 2%Sportpharm LLCd68f090d-82ea-413f-ab76-9254a88887362026-01-19Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
KETOCONAZOLEKETOCONAZOLEStrides Pharma Science Limited6d4be760-c723-4f54-a854-12c61cf917032025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: KETOCONAZOLE
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLENuCare Pharmaceuticals,Inc.4578c84a-d438-6740-e063-6294a90a01512025-12-08Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLENorthstar Rx LLCc4f711dc-d0ea-4beb-9a78-b7e3594ee4be2025-12-01Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8625ORIG1999-07-27