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 3 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KetoconazoleKETOCONAZOLEZydus Lifesciences Limitedc004ee91-558a-450b-9e4e-d11ab9d280542025-03-12Name fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLECosette Pharmaceuticals, Inc.2d7c8dd1-59b5-2645-e063-6394a90a5bda2025-02-06Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLE CREAM, 2%NuCare Pharmaceuticals,Inc.05f9938a-1577-adec-e063-6294a90af3492025-01-31Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
KetoconazoleKETOCONAZOLEDirect_Rxf5dc1e67-639f-5476-e053-2995a90a42102025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KETOCONAZOLEKETOCONAZOLEDirect Rxbc189ce2-3f10-260d-e053-2a95a90ae8082025-01-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: KETOCONAZOLE
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLENuCare Pharmaceuticals,Inc.570acb82-0c6f-0b98-e054-00144ff8d46c2024-12-26Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
ketoconazoleKETOCONAZOLEBryant Ranch Prepackac98307e-315a-4fbd-81cb-cd936f2bfbae2024-12-24Warnings, Adverse reactionsName fallback
brand name: ketoconazole
generic name: KETOCONAZOLE
KetodanKETOCONAZOLEMedimetriks Pharmaceuticals, Inc.62f19bd8-926e-4e6b-9097-d81b894b95cc2024-12-05Warnings, Adverse reactionsName fallback
generic name: KETOCONAZOLE
ketoconazoleKETOCONAZOLEBryant Ranch Prepack77989858-9f7a-45d6-97fb-deba1cba8fe82024-10-08Warnings, Adverse reactionsName fallback
brand name: ketoconazole
generic name: KETOCONAZOLE
ketoconazoleKETOCONAZOLEBryant Ranch Prepack513370d5-2e9f-4677-a0f2-63ff761429092024-10-08Warnings, Adverse reactionsName fallback
brand name: ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEBryant Ranch Prepackd0fcab34-5451-456a-a75a-b1365d5dbc2c2024-06-20Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEPadagis Israel Pharmaceuticals Ltd99da5233-2760-46f6-8fb3-d9df5da70bfb2024-05-31Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KETOCONAZOLEKETOCONAZOLEBryant Ranch Prepack3ea8a22b-cd61-4623-a11f-43e3396b50fa2024-05-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: KETOCONAZOLE
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEBryant Ranch Prepackb200ef76-5ea1-4253-bea5-1e8db02945102024-03-15Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEViona Pharmaceuticals Inca4bb3f4c-ad93-4d85-b8d0-54eaa62228fd2024-03-11Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLE CREAM, 2%Proficient Rx LP36e0bdcb-845c-452f-ad5a-a116ad657a3a2024-03-01Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
ketoconazoleKETOCONAZOLEPadagis Israel Pharmaceuticals Ltd9b65f632-a98d-400e-9ec3-84dea581d6a32024-02-29Warnings, Adverse reactionsName fallback
brand name: ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEBryant Ranch Prepack02a348b0-1325-4298-8813-83970da32c7a2024-01-11Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEBryant Ranch Prepackdc635682-170d-46ad-a9ba-6a75c6e0950e2024-01-11Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEA-S Medication Solutionsb3b99c8b-4512-4972-935d-602d4b8325c42024-01-08Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE

Reported adverse events (FAERS/openFDA)#

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