Home Applications 020333 Application 020333
Type NDA
Sponsor SHIRE LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AGRYLIN ANAGRELIDE HYDROCHLORIDE CAPSULE;ORAL EQ 0.5MG BASE No No 002 AGRYLIN ANAGRELIDE HYDROCHLORIDE CAPSULE;ORAL EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020333-001 AGRYLIN ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 N020333-002 AGRYLIN ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020333-001 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 3 · 82 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 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020333-002 AGRYLIN EQ 1MG BASE CAPSULE / ORAL RLD 1997-03-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020333-002 AGRYLIN EQ 1MG BASE CAPSULE / ORAL RLD 1997-03-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE / ORAL RLD 1997-03-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE / ORAL RLD 1997-03-14 782e0a99824c…
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 Agrylin ANAGRELIDE HYDROCHLORIDE Takeda Pharmaceuticals America, Inc. cb960074-99c1-4a73-941f-f0644a7ec219 2026-04-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 020333 application number: NDA020333 ndc (product): 54092-063
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 54092-063 Agrylin anagrelide hydrochloride Takeda Pharmaceuticals America, Inc. NDA Current 54092-063 Agrylin anagrelide hydrochloride Takeda Pharmaceuticals America, Inc. NDA Current 54092-063 Agrylin anagrelide hydrochloride Shire US Manufacturing Inc. NDA Current 54092-063 Agrylin anagrelide hydrochloride Takeda Pharmaceuticals America, Inc. NDA Current 54092-063 Agrylin anagrelide hydrochloride Takeda Pharmaceuticals America, Inc. NDA Current 54092-063 Agrylin anagrelide hydrochloride Shire US Manufacturing Inc. NDA Current