Tamsulosin hydrochloride

Product NDC
58118-0030
11-digit product format
581180030
Labeler code
58118
Product ID
58118-0030_8d8226c3-b580-4946-e053-2a95a90a4fa9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA078801
Marketing category
ANDA
Marketing start
2010-04-27
Marketing end
0000-00-00
Substance
TAMSULOSIN HYDROCHLORIDE
Active strength
0 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58118-0030DDiscontinued by firm2026-08-17
excluded packagepackage58118-003058118-0030-8DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58118-0030-8d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58118-0030-8f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58118-0030-82ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58118-0030-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58118-0030-8cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58118-0030-8cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58118-0030-8302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58118-0030-8ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58118-0030-80efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58118-0030-8ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58118-0030-8367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58118-0030-8557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage58118-0030-88af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage58118-0030-8834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage58118-0030-81332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage58118-0030-8fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage58118-0030-886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58118-0030-8bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58118-0030-88dfbde2a14a4…c9ff85d89658…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078801-001TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078801-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-273f01610625f2…
2019-09-15 20:21 UTC2019-09A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078801-001TAMSULOSIN HYDROCHLORIDE0.4MGCAPSULE / ORALAB2010-04-27e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078801-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078801-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078801-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078801-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078801-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078801-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078801-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078801-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078801-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078801-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078801-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078801-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078801-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078801-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078801-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078801-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078801-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078801-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078801-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078801-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078801-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078801-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078801-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078801-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078801-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078801-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078801-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078801-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078801-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078801-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078801-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078801-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078801-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078801-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078801-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078801-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078801-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078801-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078801-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078801-001AB1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMSULOSIN HYDROCHLORIDEACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
TAMSULOSINACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OTAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMTAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RTAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0030TAMSULOSIN HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]6Legacy NDC20190713_bc5b255a-052a-4d3f-baa3-10b20dbfb99d.zip

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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tamsulosin hydrochlorideTAMSULOSIN HYDROCHLORIDESynthon Pharmaceuticals, Inc.13a5032d-0be1-4001-916e-459f0b1a051d2025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078801
application number: ANDA078801
Tamsulosin hydrochlorideTAMSULOSIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC35bbb655-19e2-00c2-e063-6394a90afbe32025-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078801
application number: ANDA078801
Tamsulosin hydrochlorideTAMSULOSIN HYDROCHLORIDEEXELAN PHARMACEUTICALS, INC.db6cb771-2cff-40b7-a5ef-ea3cf2a3b4612025-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078801
application number: ANDA078801