FDA.reportPublic FDA data

Application 204632

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDETABLET;ORAL2.5MGNoNo
002VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDETABLET;ORAL5MGNoNo
003VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDETABLET;ORAL10MGNoNo
004VARDENAFIL 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204632-001VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-22
A204632-002VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-22
A204632-003VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-22
A204632-004VARDENAFIL HYDROCHLORIDEVARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A204632-001AB
A204632-002AB
A204632-003AB
A204632-004AB

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 22:54:322026-06A204632-001VARDENAFIL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORALAB2019-10-22a50c72e98297…
2026-08-01 22:54:322026-06A204632-002VARDENAFIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2019-10-22a50c72e98297…
2026-08-01 22:54:322026-06A204632-003VARDENAFIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2019-10-22a50c72e98297…
2026-08-01 22:54:322026-06A204632-004VARDENAFIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2019-10-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204632-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204632-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A204632-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A204632-004AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vardenafil HydrochlorideVARDENAFIL HYDROCHLORIDEMacleods Pharmaceuticals Limiteda38de6e1-21ca-4ebe-a3c7-6f849cf8b6752023-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204632
application number: ANDA204632
ndc (product): 33342-152
ndc (product): 33342-153
ndc (product): 33342-154
ndc (product): 33342-151

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33342-151Vardenafil HydrochlorideVardenafil HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-151Vardenafil HydrochlorideVardenafil HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-151Vardenafil HydrochlorideVardenafil HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-152Vardenafil HydrochlorideVardenafil HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-152Vardenafil HydrochlorideVardenafil HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-152Vardenafil HydrochlorideVardenafil HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-153Vardenafil HydrochlorideVardenafil HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-153Vardenafil HydrochlorideVardenafil HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-153Vardenafil HydrochlorideVardenafil HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-154Vardenafil HydrochlorideVardenafil HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-154Vardenafil HydrochlorideVardenafil HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-154Vardenafil HydrochlorideVardenafil HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
73750-102Vardenafil HydrochlorideVardenafil HydrochlorideQYK BRANDS LLCANDACurrent
73750-102Vardenafil HydrochlorideVardenafil HydrochlorideQYK BRANDS LLCANDACurrent
73750-103Vardenafil HydrochlorideVardenafil HydrochlorideQYK BRANDS LLCANDACurrent
73750-103Vardenafil HydrochlorideVardenafil HydrochlorideQYK BRANDS LLCANDACurrent
73750-104Vardenafil HydrochlorideVardenafil HydrochlorideQYK BRANDS LLCANDACurrent
73750-104Vardenafil HydrochlorideVardenafil HydrochlorideQYK BRANDS LLCANDACurrent
73750-105Vardenafil HydrochlorideVardenafil HydrochlorideQYK BRANDS LLCANDACurrent
73750-105Vardenafil HydrochlorideVardenafil HydrochlorideQYK BRANDS LLCANDACurrent