Home Applications 204373 Application 204373
Type ANDA
Sponsor CADILA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DUTASTERIDE DUTASTERIDE CAPSULE;ORAL 0.5MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204373-001 DUTASTERIDE DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204373-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204373-001 DUTASTERIDE 0.5MG CAPSULE / ORAL AB 2017-10-04 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 2 of 2 · 21 matching rows.
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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68382-641 Dutasteride Dutasteride Zydus Pharmaceuticals (USA) Inc. ANDA Current 70771-1347 Dutasteride Dutasteride Cadila Healthcare Limited ANDA Current 70771-1347 Dutasteride Dutasteride Cadila Healthcare Limited ANDA Current 70771-1347 Dutasteride Dutasteride Zydus Lifesciences Limited ANDA Current 70771-1347 Dutasteride Dutasteride Cadila Healthcare Limited ANDA Current 72578-019 Dutasteride Dutasteride Viona Pharmaceuticals Inc ANDA Current 72578-019 Dutasteride Dutasteride Viona Pharmaceuticals Inc ANDA Current