FDA.reportPublic FDA data

Application 219129

Type
ANDA
Sponsor
NOVITIUM PHARMA

Application Products#

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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219129-001KETOCONAZOLEKETOCONAZOLE200MGTABLET / ORALAB2025-07-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219129-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A219129-001KETOCONAZOLE200MGTABLET / ORALAB2025-07-0384e616aacf4f…
2026-08-18 06:07:402026-07A219129-001KETOCONAZOLE200MGTABLET / ORALAB2025-07-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219129-001KETOCONAZOLE200MGTABLET / ORALAB2025-07-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219129-001KETOCONAZOLE200MGTABLET / ORALAB2025-07-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A219129-001KETOCONAZOLE200MGTABLET / ORALAB2025-07-036a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219129-001KETOCONAZOLE200MGTABLET / ORALAB2025-07-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219129-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A219129-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219129-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219129-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219129-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219129-001AB1a50c72e98297…

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 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
KetoconazoleKETOCONAZOLEBryant Ranch Prepack4baebcab-a237-42c0-9183-6f447a44e3712025-11-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEGolden State Medical Supply, Inc.a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b72025-11-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
ketoconazoleKETOCONAZOLEBryant Ranch Prepacka878a39d-6d26-4ede-9667-b3e201ffc3372025-10-24Warnings, Adverse reactionsName fallback
brand name: ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEBryant Ranch Prepack6d394f8c-d49e-45ff-b7a9-a14aba9bb9cf2025-10-24Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
ketoconazoleKETOCONAZOLEBryant Ranch Prepack65dd4435-99f2-4383-b307-ba5bce9f1ca92025-10-24Warnings, Adverse reactionsName fallback
brand name: ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLE CREAM, 2%Encube Ethicals, Inc.59188ef7-5bc9-4acc-bbff-8712c41e5f772025-09-09Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
KetoconazoleKETOCONAZOLESun Pharmaceutical Industries, Inc.8ca815a8-bccb-4ee2-a042-922373329cae2025-09-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
NizoralKETOCONAZOLEKramer Laboratoriesf5c8c5b4-49bd-4dc7-8c29-8f1317c6ef882025-08-21WarningsName fallback
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLE CREAM, 2%A-S Medication Solutions750bcfc3-b0e4-407e-ad12-e81b183f3b002025-07-23Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
NizoralKETOCONAZOLEKramer Laboratories8dd6b2f1-f438-4be1-a6c4-4f6c8902dfb62025-07-11WarningsName fallback
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEGolden State Medical Supply, Inc.3e3cde4b-939f-4837-9920-bb6bb8416bd62025-07-10Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLESun Pharmaceutical Industries, Inc.39b85d6a-9133-42e6-b7f8-58f045e9b9f02025-07-07Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEAmici Pharma Inc.369f31da-d3c3-49b8-956f-f705987601642025-06-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEPreferred Pharmaceuticals Inc.39d31bed-9caa-41bb-afdb-25fc18609c142025-04-24Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEA-S Medication Solutionsa884bad7-df8c-45de-8c4f-42034b40e4252025-04-23Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
Tagrit Antifungal Treament Ketoconazole 1%KETOCONAZOLETAGRID LLC315a8832-c42f-c07a-e063-6394a90a82182025-03-27WarningsName fallback
generic name: KETOCONAZOLE
1% ketoconazoleKETOCONAZOLETAGRID LLC30b75584-3a1e-c125-e063-6294a90acaa72025-03-19WarningsName fallback
generic name: KETOCONAZOLE

Reported adverse events (FAERS/openFDA)#

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