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 3 of 8 · 144 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TadalafilTADALAFILNuCare Pharmaceuticals,Inc.cf353da9-31c6-66c2-e053-2995a90a3bb02026-01-09Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILNorthwind Health Company, LLCf3092f5a-b976-91ab-e053-2995a90a9b502026-01-01Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILNorthwind Health Company, LLCf317fe1e-d7c4-fb8b-e053-2a95a90a54452026-01-01Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILNorthwind Health Company, LLC0afd0728-256a-293b-e063-6394a90a3c5f2025-12-26Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILNorthwind Health Company, LLCf2a132af-d75e-2ca0-e053-2a95a90a332e2025-12-26Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILFOURRTS (INDIA) LABORATORIES PRIVATE LIMITED0ea97208-5afc-4943-b35c-ea850203a7942025-12-19Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
ADCIRCATADALAFILUnited Therapeutics Corporationff61b237-be8e-461b-8114-78c52a8ad0ae2025-12-15Warnings, Adverse reactionsName fallback
generic name: TADALAFIL
TadalafilTADALAFILNIVAGEN PHARMACEUTICALS, INC.ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a2025-12-09Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILQuallent Pharmaceuticals Health LLCdc14daa3-cae9-4751-9034-b0e9c18054b42025-11-30Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILQuallent Pharmaceuticals Health LLC84cb16c8-30ab-49f2-a6df-ec3c97bf62842025-11-20Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
tadalafilTADALAFILPD-Rx Pharmaceuticals, Inc.6c680b37-d515-4fc2-83e6-411f1017e18c2025-10-14Warnings, Adverse reactionsName fallback
brand name: tadalafil
generic name: TADALAFIL
TadalafilTADALAFILAjanta Pharma USA Inc.7e4cdac1-42cc-4038-a86b-4890962ed8062025-10-10Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TadalafilTADALAFILAjanta Pharma USA Inc.fceb8aaf-b4eb-4004-8ca4-f004eac6b3142025-10-10Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
tadalafilTADALAFILPD-RX Pharmaceuticals, Inc.fc7596dd-42d3-af7c-e053-6294a90af01e2025-10-09Warnings, Adverse reactionsName fallback
brand name: tadalafil
generic name: TADALAFIL
tadalafilTADALAFILPD-Rx Pharmaceuticals, Inc.5de70f00-00ac-4656-883e-d1e07d5f71d62025-10-09Warnings, Adverse reactionsName fallback
brand name: tadalafil
generic name: TADALAFIL
TadalafilTADALAFILPreferred Pharmaceuticals Inc.2354c3e2-7b5f-4fdd-bbf2-7fa3c57686f82025-09-25Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TADALAFILTADALAFILPreferred Pharmaceuticals Inc.66e24ced-0008-40cb-b242-9d9add1f665c2025-09-25Warnings, Adverse reactionsName fallback
brand name: TADALAFIL
generic name: TADALAFIL
TadalafilTADALAFILPreferred Pharmaceuticals Inc.761dc0f8-2f65-4615-ab49-a4bcffd40ce92025-09-25Warnings, Adverse reactionsName fallback
brand name: Tadalafil
generic name: TADALAFIL
TADALAFILTADALAFILPreferred Pharmaceuticals Inc.09ad27a1-3908-4533-b84c-7a7fd35141012025-09-25Warnings, Adverse reactionsName fallback
brand name: TADALAFIL
generic name: TADALAFIL
TadalafilTADALAFILMacleods Pharmaceuticals Limited4348b7db-e5b2-4e87-8cdd-674797a188902025-09-17Warnings, 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.