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 4 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KetoconazoleKETOCONAZOLEA-S Medication Solutions8ef1117d-0b63-4c26-beaa-7667b2387e142023-11-17Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KETOCONAZOLEKETOCONAZOLEA-S Medication Solutions517c29fc-2a2a-4bd5-a8bb-b464a65d2be02023-11-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: KETOCONAZOLE
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEA-S Medication Solutionsc29d4ddc-aa1c-41c6-99ce-9aff35d213f62023-09-25Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KETOCONAZOLEKETOCONAZOLEBurel Pharmaceuticals, LLC57e81e13-b395-4dbd-b660-3038de41a8382023-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: KETOCONAZOLE
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEProficient Rx LPcb1908da-443d-40b8-b8c7-b115bc2d37e02022-11-01Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLEProficient Rx LP4f08caf2-a57c-4146-9289-532711bbdbcd2022-04-01Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLETeva Pharmaceuticals USA, Inc.7fc47a6a-3714-4598-ae3b-d5a229262c212021-09-02Warnings, Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLETOLMAR Inc.7036d1f2-c3f9-41d4-bc72-dd70e16911282020-06-03Adverse reactionsName fallback
brand name: Ketoconazole
generic name: KETOCONAZOLE
KetoconazoleKETOCONAZOLE FOAMXiromed, LLCea319889-5e58-f778-3009-5ba6a5f2690a2019-09-23Warnings, Adverse reactionsName fallback
brand name: Ketoconazole

Reported adverse events (FAERS/openFDA)#

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