FDA.reportPublic FDA data

Application 203689

Type
ANDA
Sponsor
WATSON LABS TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDETABLET, ORALLY DISINTEGRATING;ORAL10MGNoNo

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 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEBryant Ranch Prepack083a3282-254f-4042-b0eb-70f76a279f102026-08-27Warnings, Adverse reactionsName fallback
brand name: Vardenafil Hydrochloride
generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEBryant Ranch Prepack6d2859a7-6def-455f-856b-9db86b1fd3552026-08-27Warnings, Adverse reactionsName fallback
brand name: Vardenafil Hydrochloride
generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEBryant Ranch Prepack666a622b-2464-4c55-8c90-0f1cc85bc1e92026-08-26Warnings, Adverse reactionsName fallback
brand name: Vardenafil Hydrochloride
generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEBryant Ranch Prepack8791997d-3b86-45af-988f-808e259da5062026-08-26Warnings, Adverse reactionsName fallback
brand name: Vardenafil Hydrochloride
generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDELannett Company, Inc.2782efed-6198-47b9-81ac-3e255e2ab7f62026-07-15Warnings, Adverse reactionsName fallback
brand name: Vardenafil Hydrochloride
generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEAvKARE80c4793d-e19e-10f0-e053-2991aa0a46202026-01-15Warnings, Adverse reactionsName fallback
brand name: Vardenafil Hydrochloride
generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEChartwell RX, LLC57a0c163-a5e8-4c6e-a4ea-114cb26684072025-12-10Warnings, Adverse reactionsName fallback
brand name: Vardenafil Hydrochloride
generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEAvKARE3b03952b-d404-09cd-e063-6294a90a8b2c2025-07-28Warnings, Adverse reactionsName fallback
brand name: Vardenafil Hydrochloride
generic name: VARDENAFIL HYDROCHLORIDE
VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEBryant Ranch Prepackd8a5cc4b-9d9d-43af-9ee4-57381aa6368a2024-05-28Warnings, Adverse reactionsName fallback
brand name: VARDENAFIL HYDROCHLORIDE
generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEBryant Ranch Prepack31be68b0-ac7e-42d0-9435-1f0a329b63d82024-04-03Warnings, Adverse reactionsName fallback
brand name: Vardenafil Hydrochloride
generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDETeva Pharmaceuticals USA, Inc.e593ab58-70a4-4095-8091-16a4b6d49e4d2023-12-08Warnings, Adverse reactionsName fallback
brand name: Vardenafil Hydrochloride
generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEMacleods Pharmaceuticals Limiteda38de6e1-21ca-4ebe-a3c7-6f849cf8b6752023-04-10Warnings, Adverse reactionsName fallback
brand name: Vardenafil Hydrochloride
generic name: VARDENAFIL HYDROCHLORIDE
VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEAlembic Pharmaceuticals Inc.d2dce236-257e-44b6-93a9-9f0280257c6a2023-03-22Warnings, Adverse reactionsName fallback
brand name: VARDENAFIL HYDROCHLORIDE
generic name: VARDENAFIL HYDROCHLORIDE
VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEAlembic Pharmaceuticals Limited9b8da728-8f52-4c1f-9f0c-4bd9736e912f2023-01-24Warnings, Adverse reactionsName fallback
brand name: VARDENAFIL HYDROCHLORIDE
generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC09366eb3-93e0-41d9-bf9a-24335ed3555f2021-01-27Warnings, Adverse reactionsName fallback
brand name: Vardenafil Hydrochloride
generic name: VARDENAFIL HYDROCHLORIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49263ORIG2017-08-07