Home Applications 022460 Application 022460
Type NDA
Sponsor GLAXOSMITHKLINE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 JALYN DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE CAPSULE;ORAL 0.5MG;0.4MG Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022460-001 JALYN DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE 0.5MG;0.4MG CAPSULE / ORAL AB RLD 2010-06-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022460-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD 2010-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD 2010-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022460-001 JALYN 0.5MG;0.4MG CAPSULE / ORAL AB RLD, RS 2010-06-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Jalyn DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE Waylis Therapeutics aab9a2d4-5328-40f3-986f-e7753a928bc0 2026-03-09 Warnings, Adverse reactions Exact identifier application applno (NDA): 022460 application number: NDA022460
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0173-0809 JALYN dutasteride and tamsulosin hydrochloride GlaxoSmithKline LLC NDA Current 0173-0809 JALYN dutasteride and tamsulosin hydrochloride GlaxoSmithKline LLC NDA Current 0173-0809 JALYN dutasteride and tamsulosin hydrochloride GlaxoSmithKline LLC NDA Current 0173-0809 JALYN dutasteride and tamsulosin hydrochloride GlaxoSmithKline LLC NDA Current 0173-0809 JALYN dutasteride and tamsulosin hydrochloride GlaxoSmithKline LLC NDA Current 66993-580 Dutasteride and Tamsulosin Hydrochloride dutasteride and tamsulosin hydrochloride Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-580 Dutasteride and Tamsulosin Hydrochloride dutasteride and tamsulosin hydrochloride Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-580 Dutasteride and Tamsulosin Hydrochloride dutasteride and tamsulosin hydrochloride Prasco Laboratories NDA AUTHORIZED GENERIC Current