Application 211885

Type
ANDA
Sponsor
ANBISON LAB

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 43.

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
A211885-001TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211885-001AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-1784e616aacf4f…
2026-08-18 06:07:402026-07A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2019-10-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2019-10-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2019-10-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORAL2019-10-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-173f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211885-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2019-10-17cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A211885-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A211885-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211885-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211885-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211885-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211885-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211885-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211885-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211885-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211885-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211885-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211885-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211885-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211885-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211885-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211885-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211885-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211885-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211885-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211885-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211885-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211885-001AB1782e0a99824c…
2019-12-14 00:12 UTC2019-12A211885-001AB13f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211885-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211885-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211885-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211885-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211885-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211885-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211885-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211885-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211885-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211885-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211885-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211885-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211885-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211885-001AB1a50c72e98297…

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 2 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEAvKARE43bec742-fbc4-39af-e063-6294a90ac7342025-11-16Warnings, 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
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f6b6aeab-bedd-4254-8811-4f65cf8a351f2025-10-17Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEGolden State Medical Supply, Inc.18e9741b-969a-5a87-e063-6294a90a88512025-10-13Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEA-S Medication Solutions6a2a4cc7-c88a-4555-a247-d1e63206ffc52025-10-02Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEA-S Medication Solutions00bb2d71-1f21-494c-aa66-a82be3a0a8e62025-10-02Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEA-S Medication Solutions1d70b04e-ca08-48d3-937b-eb701b40dd8a2025-10-02Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepackf185abfc-367d-45da-87c4-86d9f70bcd5d2025-09-29Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEPreferred Pharmaceuticals, Inc.82d65964-de00-42c2-baaa-cc3de744b8eb2025-09-25Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEAscend Laboratories, LLCed9988bc-0759-4c36-bee1-11b68dc1c84c2025-08-04Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEAmerican Health Packaging8150a710-aee5-4841-ae1b-7d2e61281a8f2025-07-01Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepack3533e74e-5706-f594-e063-6394a90ab8a72025-06-13Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEBryant Ranch Prepack36b8c36f-22e5-40f5-a99a-411115f13df42025-05-23Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin hydrochlorideTAMSULOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC35bbb655-19e2-00c2-e063-6394a90afbe32025-05-22Warnings, Adverse reactionsName fallback
brand name: Tamsulosin hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEXLCare Pharmaceuticals, Inc9108b999-4b99-469d-99a8-5ef0fa4ca00a2025-03-28Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCc3ae55dd-6a0e-4f3a-82b6-2448e05455502025-03-20Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin hydrochlorideTAMSULOSIN HYDROCHLORIDEEXELAN PHARMACEUTICALS, INC.db6cb771-2cff-40b7-a5ef-ea3cf2a3b4612025-03-01Warnings, Adverse reactionsName fallback
brand name: Tamsulosin hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.cfd48327-a528-58cc-e053-2995a90a129f2025-02-10Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
Tamsulosin HydrochlorideTAMSULOSIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.b85769ba-814e-1adb-e053-2a95a90a05562025-01-02Warnings, Adverse reactionsName fallback
brand name: Tamsulosin Hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE
tamsulosin hydrochlorideTAMSULOSIN HYDROCHLORIDESandoz Incfb120098-b007-4a33-80b8-b7279c7668ee2024-09-30Warnings, Adverse reactionsName fallback
brand name: tamsulosin hydrochloride
generic name: TAMSULOSIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60723-056Tamsulosin HydrochlorideTamsulosin HydrochlorideHangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.ANDACurrent
73750-099Tamsulosin hydrochlorideTamsulosin hydrochlorideQYK BRANDS LLCANDACurrent
73750-099Tamsulosin hydrochlorideTamsulosin hydrochlorideQYK BRANDS LLCANDACurrent
73750-099Tamsulosin hydrochlorideTamsulosin hydrochlorideQYK BRANDS LLCANDACurrent