FDA.reportPublic FDA data

Application 210738

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDETABLET;ORAL5MGNoNo
002VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDETABLET;ORAL10MGNoNo
003VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDETABLET;ORAL20MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210738-001VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2018-10-31
A210738-002VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2018-10-31
A210738-003VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2018-10-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A210738-001VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2018-10-31a50c72e98297…
2026-08-01 22:54:322026-06A210738-002VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2018-10-31a50c72e98297…
2026-08-01 22:54:322026-06A210738-003VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2018-10-31a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 HYDROCHLORIDEBryant Ranch Prepack083a3282-254f-4042-b0eb-70f76a279f102025-11-06Warnings, Adverse reactionsName fallback
brand name: Vardenafil Hydrochloride
generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEBryant Ranch Prepack6d2859a7-6def-455f-856b-9db86b1fd3552025-11-06Warnings, Adverse reactionsName fallback
brand name: Vardenafil Hydrochloride
generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEBryant Ranch Prepack666a622b-2464-4c55-8c90-0f1cc85bc1e92025-10-28Warnings, Adverse reactionsName fallback
brand name: Vardenafil Hydrochloride
generic name: VARDENAFIL HYDROCHLORIDE
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEBryant Ranch Prepack8791997d-3b86-45af-988f-808e259da5062025-10-28Warnings, 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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1151Vardenafil hydrochlorideVardenafil hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1151Vardenafil hydrochlorideVardenafil hydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1151Vardenafil hydrochlorideVardenafil hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1151Vardenafil hydrochlorideVardenafil hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1152Vardenafil hydrochlorideVardenafil hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1152Vardenafil hydrochlorideVardenafil hydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1152Vardenafil hydrochlorideVardenafil hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1152Vardenafil hydrochlorideVardenafil hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1153Vardenafil hydrochlorideVardenafil hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1153Vardenafil hydrochlorideVardenafil hydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1153Vardenafil hydrochlorideVardenafil hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1153Vardenafil hydrochlorideVardenafil hydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent