FDA.reportPublic FDA data

Application 090141

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TADALAFILTADALAFILTABLET;ORAL2.5MGNoNo
002TADALAFILTADALAFILTABLET;ORAL5MGNoNo
003TADALAFILTADALAFILTABLET;ORAL10MGNoNo
004TADALAFILTADALAFILTABLET;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
A090141-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12018-05-22
A090141-002TADALAFILTADALAFIL5MGTABLET / ORALAB12018-05-22
A090141-003TADALAFILTADALAFIL10MGTABLET / ORALAB12018-05-22
A090141-004TADALAFILTADALAFIL20MGTABLET / ORALAB12018-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090141-001AB1
A090141-002AB1
A090141-003AB1
A090141-004AB1

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 22:54:322026-06A090141-001TADALAFIL2.5MGTABLET / ORALAB12018-05-22a50c72e98297…
2026-08-01 22:54:322026-06A090141-002TADALAFIL5MGTABLET / ORALAB12018-05-22a50c72e98297…
2026-08-01 22:54:322026-06A090141-003TADALAFIL10MGTABLET / ORALAB12018-05-22a50c72e98297…
2026-08-01 22:54:322026-06A090141-004TADALAFIL20MGTABLET / ORALAB12018-05-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090141-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A090141-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A090141-003AB11a50c72e98297…
2026-08-01 22:54:322026-06A090141-004AB11a50c72e98297…

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 7 · 138 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TadalafilTADALAFILREMEDYREPACK INC.415bd983-86f3-4f38-917a-9805024f31cb2026-07-09Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILBryant Ranch Prepack07567ae5-7345-4ab1-9b2c-c586c4da04272026-06-24Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TADALAFILTADALAFILREMEDYREPACK INC.cec49f6c-71f1-4de7-b515-1612ae16e5db2026-06-11Warnings, Adverse reactionsName fallback
brand name: TADALAFIL
generic name: TADALAFIL
TADALAFILTADALAFILREMEDYREPACK INC.89a33a41-0f01-4f29-8b2f-769d649fbdcb2026-06-10Warnings, Adverse reactionsName fallback
brand name: TADALAFIL
generic name: TADALAFIL
CialisTADALAFILEli Lilly and Companybcd8f8ab-81a2-4891-83db-24a0b0e258952026-06-03Warnings, Adverse reactionsName fallback
generic name: TADALAFIL
TADALAFILTADALAFILBryant Ranch Prepackb3a58c17-f260-4125-abd1-27da00bb07192026-05-29Warnings, Adverse reactionsName fallback
brand name: TADALAFIL
generic name: TADALAFIL
TadalafilTADALAFILREMEDYREPACK INC.ad288e9d-020a-43a0-9c07-320c5c3bbc1e2026-05-27Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
tadalafilTADALAFILRedpharm Drug52505a7a-e3dd-7c4e-e063-6294a90a14732026-05-21Warnings, Adverse reactionsName fallback
brand name: tadalafil
generic name: TADALAFIL
TADALAFILTADALAFILNuCare Pharmaceuticals,Inc..16f13179-7c87-aa6c-e063-6294a90a93eb2026-05-19Warnings, Adverse reactionsName fallback
brand name: TADALAFIL
generic name: TADALAFIL
TadalafilTADALAFILBryant Ranch Prepack2c2ec257-06bc-4ca4-9cf3-d0f49980e3742026-05-14Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILBryant Ranch Prepackaa8d165b-0c7d-497a-b56a-7c62ebc0a5d22026-05-13Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILBryant Ranch Prepackf8def23c-55ea-4796-9735-dbcb251048352026-05-13Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILBryant Ranch Prepackc835a34a-9bae-4d88-b951-1b78ab92f3882026-05-13Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILUmedica Laboratories USA Inc.6caf3b55-9bf4-4355-9e25-8bf368943fdd2026-04-26Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TADALAFILTADALAFILREMEDYREPACK INC.82dfea4c-9fe5-438a-917f-8f7d395ee8ca2026-04-23Warnings, Adverse reactionsName fallback
brand name: TADALAFIL
generic name: TADALAFIL
TadalafilTADALAFILAccord Healthcare Inc.eedf3ad9-7d40-496d-b1a9-6200010c18e12026-04-16Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILAmneal Pharmaceuticals NY LLC90f38460-62ad-492e-a3da-403d5a5a5d862026-04-15Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TADALAFILTADALAFILAphena Pharma Solutions - Tennessee, LLC351e28ca-3ae6-e535-e063-6394a90a9fb72026-03-23Warnings, Adverse reactionsName fallback
brand name: TADALAFIL
generic name: TADALAFIL
TADALAFILTADALAFILTorrent Pharmaceuticals Limited88132351-7fee-47ef-8007-ef27775432992026-03-05Warnings, Adverse reactionsName fallback
brand name: TADALAFIL
generic name: TADALAFIL
TADALAFILTADALAFILHEC Pharm USA Inc.a0f728b6-2cc6-cb65-e053-2a95a90ab1422026-03-05Warnings, Adverse reactionsName fallback
brand name: TADALAFIL
generic name: TADALAFIL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3016TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3016TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3016TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3016TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3016TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3016TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3016TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3017TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3017TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3017TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3017TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3017TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3017TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3017TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3018TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3018TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3018TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3018TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3018TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3018TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3018TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3019TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3019TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3019TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3019TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3019TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3019TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3019TadalafilTadalafilTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-786TadalafilTadalafilAvkareANDACurrent
42291-786TadalafilTadalafilAvkareANDACurrent
42291-787TadalafilTadalafilAvKARE, Inc.ANDACurrent
42291-787TadalafilTadalafilAvKAREANDACurrent
42291-788TadalafilTadalafilAvKARE, Inc.ANDACurrent
42291-788TadalafilTadalafilAvKAREANDACurrent
42291-789TadalafilTadalafilAvKARE, Inc.ANDACurrent
42291-789TadalafilTadalafilAvKAREANDACurrent
71205-418TadalafilTadalafilProficient Rx LPANDACurrent
71610-353TadalafilTadalafilAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-354TadalafilTadalafilAphena Pharma Solutions - Tennessee, LLCANDACurrent
76519-1225TADALAFILTADALAFILH.J. Harkins Company, Inc.ANDACurrent
76519-1226TADALAFILTADALAFILH.J. Harkins Company, Inc.ANDACurrent
76519-1227TADALAFILTADALAFILH.J. Harkins Company, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54440ORIG2018-06-05
50724ORIG2017-12-18