FDA.reportPublic FDA data

Application 219767

Type
ANDA
Sponsor
RISING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDECAPSULE;ORAL0.4MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219767-001TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2025-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219767-001AB

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
2026-02-19 14:30 UTC2026-02A219767-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2025-05-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219767-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2025-05-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219767-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2025-05-016a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219767-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2025-05-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219767-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219767-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219767-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219767-001AB1a50c72e98297…

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 1 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEREMEDYREPACK INC.a608ddc8-fe42-484e-b61f-307c601511382026-07-16Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepacke9372720-bd02-e4a6-0afd-42fe0c661c002026-07-06Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEREMEDYREPACK INC.b30e2bde-b20e-4899-a100-f44170d8165b2026-06-24Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDECardinal Health 107, LLC5ed219aa-cf65-457f-8570-d26b48edb2402026-06-17Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDECoupler LLC52bbe73b-43b6-3393-e063-6294a90a6dc62026-05-26Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepack59d0e07c-0018-4681-beb2-cb1c8e2637ee2026-05-14Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDESt. Marys Medical Park Pharmacy6142d7b6-e5ea-1af0-e053-2991aa0a00cd2026-05-05Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDEDIRECT RX7a420aca-31e6-8e0c-e053-2a91aa0a1be02026-04-22Warnings, Adverse reactionsName fallback
brand name: TAMSULOSIN HYDROCHLORIDE
generic name: TAMSULOSIN HYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDEDirect_Rx8de50eca-8cc5-082d-e053-2a95a90a346d2026-04-13Warnings, Adverse reactionsName fallback
brand name: TAMSULOSIN HYDROCHLORIDE
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepackfd73ddfd-3773-45b2-9795-9e58744a68032026-03-19Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDERedpharm Drug4d481f6b-0232-d4af-e063-6394a90ad1af2026-03-18Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f543f5d1-3348-4066-99a4-7a00aee1530d2026-01-22Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDERising Pharma Holdings, Inc.a242c8dc-576e-4a1f-a9e7-a05d7ebc0e0a2026-01-05Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDENorthwind Health Company, LLCd9df4fe0-90ab-0d96-e053-2a95a90a5ff12026-01-01Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
tamsulosin hydrochlorideTAMSULOSIN HYDROCHLORIDEXLCare Pharmaceuticals, Inc.00097e78-9c04-4e62-8260-ddb50e9a6a932026-01-01Warnings, Adverse reactionsName fallback
brand name: tamsulosin hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEChartwell RX, LLC14db58df-7584-410b-8cf4-4b928dada8592025-12-11Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin hydrochlorideTAMSULOSIN HYDROCHLORIDESynthon Pharmaceuticals, Inc.13a5032d-0be1-4001-916e-459f0b1a051d2025-12-01Warnings, Adverse reactionsName fallback
brand name: Tamsulosin hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEAvKARE43bec742-fbc4-39af-e063-6294a90ac7342025-11-16Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDECardinal Health 107, LLC0e3206ba-db3e-40b3-b46b-c7ae4703fdea2025-10-30Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEAvPAK62fa7fdf-c588-6f79-e053-2a91aa0a4c192025-10-22Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE