FDA.reportPublic FDA data

Application 079020

Type
ANDA
Sponsor
SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE; ORAL10MGNoNo
002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE; ORAL18MGNoNo
003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE; ORAL25MGNoNo
004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE; ORAL40MGNoNo
005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE; ORAL60MGNoNo
006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE; ORAL80MGNoNo
007ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE; ORAL100MGNoNo

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 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
StratteraATOMOXETINE HYDROCHLORIDEEli Lilly and Company309de576-c318-404a-bc15-660c2b1876fb2026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ATOMOXETINE HYDROCHLORIDE
Atomoxetine hydrochlorideATOMOXETINE HYDROCHLORIDEAdvagen Pharma Ltd.16096e9c-2dcd-4c84-a1a8-1c85d6d6898c2026-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atomoxetine hydrochloride
generic name: ATOMOXETINE HYDROCHLORIDE
ATONCYATOMOXETINE HYDROCHLORIDEValidus Pharmaceuticals LLC72d3d8cf-7f3b-479e-bd9f-e204d41185172026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ATOMOXETINE HYDROCHLORIDE
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEAvPAK9e787cc2-5d0f-f231-e053-2a95a90ae99a2026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atomoxetine Hydrochloride
generic name: ATOMOXETINE HYDROCHLORIDE
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEAvPAKa9df4617-b406-70ba-e053-2995a90a28e82025-12-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atomoxetine Hydrochloride
generic name: ATOMOXETINE HYDROCHLORIDE
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEREMEDYREPACK INC.6d7ea8f7-981c-4acc-aeaf-7516325bfc0c2025-10-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atomoxetine Hydrochloride
generic name: ATOMOXETINE HYDROCHLORIDE
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.6f14ced9-c16c-905a-e053-2a91aa0a031e2025-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atomoxetine Hydrochloride
generic name: ATOMOXETINE HYDROCHLORIDE
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEApotex Corp.132852a6-5bff-15dd-255c-98309dd836302025-04-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atomoxetine Hydrochloride
generic name: ATOMOXETINE HYDROCHLORIDE
Atomoxetine HydrochlorideATOMOXETINE HYDROCHLORIDEA-S Medication Solutions19b10860-aa08-4480-816c-c207819e5f9e2023-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atomoxetine Hydrochloride
generic name: ATOMOXETINE HYDROCHLORIDE