FDA.reportPublic FDA data

Application 220284

Type
ANDA
Sponsor
GRANULES PHARMACEUTICALS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002AMPHETAMINEAMPHETAMINETABLET, EXTENDED RELEASE10MGNoNo
003AMPHETAMINEAMPHETAMINETABLET, EXTENDED RELEASE15MGNoNo
004AMPHETAMINEAMPHETAMINETABLET, EXTENDED RELEASE20MGNoNo

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 1 ยท 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Adzenys XR-ODTAMPHETAMINENeos Therapeutics Brands, LLCc1179269-00b5-48ea-972d-31e614e99b7e2026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE
Dyanavel XRAMPHETAMINENextWave Pharmaceuticals, Incae304b29-0b40-40ec-ad0d-76b742d4a9b92026-02-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE
Amphetamine SulfateAMPHETAMINEAmneal Pharmaceuticals NY LLC53d40847-e0d3-48ec-81a7-ec54785535652025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE
AmphetamineAMPHETAMINETeva Pharmaceuticals, Inc.243e88e7-6621-47e9-8d5c-3f79bcb088bb2025-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Amphetamine
generic name: AMPHETAMINE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84994ORIG 2026-02-11