FDA.reportPublic FDA data

Application 210329

Type
ANDA
Sponsor
JUBILANT GENERICS

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 43.

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
A210329-001TADALAFILTADALAFIL2.5MGTABLET / ORALAB12026-05-15
A210329-002TADALAFILTADALAFIL5MGTABLET / ORALAB12026-05-15
A210329-003TADALAFILTADALAFIL10MGTABLET / ORALAB12026-05-15
A210329-004TADALAFILTADALAFIL20MGTABLET / ORALAB12026-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210329-001AB1
A210329-002AB1
A210329-003AB1
A210329-004AB1

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
2026-09-14 22:38:342026-08A210329-001TADALAFIL2.5MGTABLET / ORALAB12026-05-1584e616aacf4f…
2026-09-14 22:38:342026-08A210329-002TADALAFIL5MGTABLET / ORALAB12026-05-1584e616aacf4f…
2026-09-14 22:38:342026-08A210329-003TADALAFIL10MGTABLET / ORALAB12026-05-1584e616aacf4f…
2026-09-14 22:38:342026-08A210329-004TADALAFIL20MGTABLET / ORALAB12026-05-1584e616aacf4f…
2026-08-18 06:07:402026-07A210329-001TADALAFIL2.5MGTABLET / ORALAB12026-05-15caaa826d4ba7…
2026-08-18 06:07:402026-07A210329-002TADALAFIL5MGTABLET / ORALAB12026-05-15caaa826d4ba7…
2026-08-18 06:07:402026-07A210329-003TADALAFIL10MGTABLET / ORALAB12026-05-15caaa826d4ba7…
2026-08-18 06:07:402026-07A210329-004TADALAFIL20MGTABLET / ORALAB12026-05-15caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210329-001TADALAFIL2.5MGTABLET / ORALAB12026-05-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210329-002TADALAFIL5MGTABLET / ORALAB12026-05-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210329-003TADALAFIL10MGTABLET / ORALAB12026-05-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210329-004TADALAFIL20MGTABLET / ORALAB12026-05-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A210329-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A210329-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08A210329-003AB1184e616aacf4f…
2026-09-14 22:38:342026-08A210329-004AB1184e616aacf4f…
2026-08-18 06:07:402026-07A210329-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A210329-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A210329-003AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A210329-004AB11caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210329-001AB11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210329-002AB11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210329-003AB11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210329-004AB11a50c72e98297…

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 6 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TadalafilTADALAFILAurobindo Pharma Limiteda0ecc7cf-20dd-485a-b4dd-1bbc587280a72024-06-03Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILAurobindo Pharma Limited0345b81b-f946-4dd6-b49d-2a2bdd4c49c92024-05-24Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILBryant Ranch Prepacka73b0e6f-09fc-42d6-a678-1409ce746bd12024-05-17Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TADALAFILTADALAFILAsclemed USA, Inc.101f44e4-669c-4e3d-843a-a27157750f9c2024-05-07Warnings, Adverse reactionsName fallback
brand name: TADALAFIL
generic name: TADALAFIL
TADALAFILTADALAFILNuCare Pharmaceuticals,Inc.17947ccd-6f0e-d4cd-e063-6294a90a108a2024-05-03Warnings, Adverse reactionsName fallback
brand name: TADALAFIL
generic name: TADALAFIL
TadalafilTADALAFILBryant Ranch Prepack6fd94914-0c9d-4268-8ed8-3c2690707a5d2024-04-05Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILBryant Ranch Prepacka3190ceb-fb3f-45f7-a12d-4c333edaadc62024-04-03Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILProficient Rx LPa930511d-110e-4d2e-a4ca-df712f968b2d2024-04-01Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILProficient Rx LP78b6659c-3a46-4998-9151-1a53afd833752024-04-01Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILAphena Pharma Solutions - Tennessee, LLCd1dd9d05-e9d3-49ea-aeda-047536a270372024-03-28Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
tadalafilTADALAFILNuCare Pharmaceuticals,Inc.13a107ba-cbbd-7760-e063-6394a90a1ee82024-03-14Warnings, Adverse reactionsName fallback
brand name: tadalafil
generic name: TADALAFIL
tadalafilTADALAFILUnichem Pharmaceuticals (USA), Inc.a7b3937e-ff03-436a-a5d4-92a4771034b62024-01-31Warnings, Adverse reactionsName fallback
brand name: tadalafil
generic name: TADALAFIL
TadalafilTADALAFILA-S Medication Solutionsb9d71483-861b-465b-846b-d7bfd6cbac112023-12-26Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILA-S Medication Solutionsc1c8feb4-a85a-4f39-8c44-bc9cd77226f42023-12-21Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILLupin Pharmaceuticals, Inc.efa03afa-c412-4b31-bf26-7c3a6f7311af2023-12-14Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILCamber Pharmaceuticals, Inc.dc0a6a03-5ef1-4507-b888-5b559653c3e92023-11-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILNorthStar RxLLC594acc15-a5bc-43b5-9659-a864b2c46eea2023-11-10Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILZydus Pharmaceuticals USA Inc.cfe43ab8-8721-4db8-8810-f0072cf8f4d32023-11-08Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILProficient Rx LP7dfb450b-4d39-40e7-b115-9a96023052a02023-11-01Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILAsclemed USA, Inc.51f87c9b-038c-4793-b0d5-5359ae2310742023-10-31Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL

Reported adverse events (FAERS/openFDA)#

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