FDA.reportPublic FDA data

Application 077892

Type
ANDA
Sponsor
CARACO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MODAFINILMODAFINILTABLET; ORAL100MGNoNo
002MODAFINILMODAFINILTABLET; ORAL200MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ModafinilMODAFINILApotex Corp.944daf47-49a6-93ca-e348-4a0f1b6d937e2026-07-21Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL
ModafinilMODAFINILPreferred Pharmaceuticals Inc.60ec6e2a-2576-498f-9a8c-fddc53d4a44c2026-07-17Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL
ModafinilMODAFINILPreferred Pharmaceuticals Inc.013450dd-cd42-46c7-98d6-9a29257619782026-07-14Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL
ModafinilMODAFINILGolden State Medical Supply, Inc.1d4c6858-5b2f-f216-e063-6394a90aad5d2026-03-16Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL
ModafinilMODAFINILAphena Pharma Solutions - Tennessee, LLC4c9c4e61-517c-a9d2-e063-6394a90a58c72026-03-09Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL
ModafinilMODAFINILAphena Pharma Solutions - Tennessee, LLC4aa3bdad-163f-fda1-e063-6394a90ae1d82026-02-12Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL
ModafinilMODAFINILAvPAK4790bbe9-d753-1067-02ee-9536011650d92026-01-08Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL
ModafinilMODAFINILAphena Pharma Solutions - Tennessee, LLC463bb960-a0b5-4ca4-e063-6294a90a683b2025-12-18Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL
ModafinilMODAFINILGolden State Medical Supply, Inc.457662d8-b95c-d3af-e063-6294a90a883e2025-12-08Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL
ProvigilMODAFINILGolden State Medical Supply, Inc.3b8d1c32-dac9-50e6-e063-6394a90aa5a52025-10-16Warnings, Adverse reactionsName fallback
generic name: MODAFINIL
ProvigilMODAFINILApotex Corp0391f182-1958-9fef-a944-53b229ce99e72025-08-27Warnings, Adverse reactionsName fallback
generic name: MODAFINIL
ModafinilMODAFINILMajor Pharmaceuticals4a7ab52b-db31-4774-a06a-b11f2bb606622025-03-11Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL
ModafinilMODAFINILAphena Pharma Solutions - Tennessee, LLC2bc3cd03-2726-f693-e063-6294a90a7a032025-02-21Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL
ModafinilMODAFINILAmerican Health Packaging928a3ab6-b53c-4924-882c-9f2f49aba0f12024-10-31Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL
ModafinilMODAFINILBryant Ranch Prepack3f733d7f-1213-4534-9433-0eb99a5abc2c2024-09-23Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL
ModafinilMODAFINILBryant Ranch Prepack963aa6be-5aed-4865-b375-8c2c3102e7bc2024-08-27Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL
ModafinilMODAFINILZydus Lifesciences Limitedf39820fb-8248-4d42-854c-6fe2d9b92d362024-08-16Name fallback
brand name: Modafinil
generic name: MODAFINIL
ModafinilMODAFINILBryant Ranch Prepackf1ff7c6d-df04-48dd-a971-454d38e7d9972024-07-09Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL
ModafinilMODAFINILBryant Ranch Prepackf0c43046-fc86-4b62-bd0f-704a6894625d2024-07-08Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL
ModafinilMODAFINILProficient Rx LPc332ea93-48d9-4c8a-a1ef-01c27a61350b2024-07-01Warnings, Adverse reactionsName fallback
brand name: Modafinil
generic name: MODAFINIL