FDA.reportPublic FDA data

Application 214202

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE, CHEWABLE;ORAL20MGNoNo
002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE, CHEWABLE;ORAL30MGNoNo
003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE, CHEWABLE;ORAL40MGNoNo

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 4 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDELupin Pharmaceuticals,Inc.57fd619e-687d-403c-a77a-3dc3a1bab65a2023-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDELupin Pharmaceuticals,Inc.5bfe50ed-171f-4c40-bc0b-20c68e8e20252023-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEEywa Pharma Inc298fb86d-7d94-49e1-b743-3e78011224222023-11-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
MethylinMETHYLPHENIDATE HYDROCHLORIDESHIONOGI INC.9e3c22d9-71d9-46a7-b315-8021c94c4bec2023-11-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDESpecGx LLC981a2ad8-33f7-4678-9162-9df9685bd4a62023-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.91833146-fa95-471a-8b8d-6d36a2db5c9a2023-09-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals Inc.bb73cd3e-aa7c-4f7e-826d-75e71fb6d1e02023-09-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLC59de488c-c3f8-415d-9e9f-9102c090aac82023-02-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METHYLPHENIDATE HYDROCHLORIDE
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAscend Laboratories, LLC5fa3da25-13aa-4ee3-acf5-cd505f4688d02021-12-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEDr.Reddys Laboratories Inc7124df7e-6273-a68d-6e35-dc06122d86862021-12-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals Inc94dc74d4-b4ef-45bc-b502-54ec692e9bd52021-08-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METHYLPHENIDATE HYDROCHLORIDE
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals, Inc.b9af3104-172d-4975-9301-b9fe7db9ef122021-08-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.b07150db-fd99-4400-bb83-b3a7544a917a2021-08-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate HydrochlorideMETHYLPHENIDATE HYDROCHLORIDEAscent Pharmaceuticals, Inc.45ebb59c-9603-4df6-b1be-3295ba2db1e72021-01-29Warnings, Adverse reactionsName fallback
brand name: Methylphenidate Hydrochloride
generic name: METHYLPHENIDATE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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