Home Applications 212727 Application 212727
Type ANDA
Sponsor METHOD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 1MG BASE No No 002 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 2MG BASE No No 003 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 4MG BASE No No 004 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE TABLET;ORAL EQ 8MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212727-001 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 A212727-002 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 A212727-003 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 A212727-004 DOXAZOSIN MESYLATE DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 · 120 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 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212727-001 DOXAZOSIN MESYLATE EQ 1MG BASE TABLET / ORAL AB 2022-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212727-002 DOXAZOSIN MESYLATE EQ 2MG BASE TABLET / ORAL AB 2022-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212727-003 DOXAZOSIN MESYLATE EQ 4MG BASE TABLET / ORAL AB 2022-03-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212727-004 DOXAZOSIN MESYLATE EQ 8MG BASE TABLET / ORAL AB 2022-03-15 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 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 Doxazosin DOXAZOSIN Rising Pharma Holdings, Inc. 508b908e-8d80-422e-8ec0-2081185f4c95 2024-06-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 212727 application number: ANDA212727
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 58657-820 Doxazosin Doxazosin Method Pharmaceuticals, LLC ANDA Current 58657-820 Doxazosin Doxazosin Method Pharmaceuticals, LLC ANDA Current 58657-821 Doxazosin Doxazosin Method Pharmaceuticals, LLC ANDA Current 58657-821 Doxazosin Doxazosin Method Pharmaceuticals, LLC ANDA Current 58657-822 Doxazosin Doxazosin Method Pharmaceuticals, LLC ANDA Current 58657-822 Doxazosin Doxazosin Method Pharmaceuticals, LLC ANDA Current 58657-823 Doxazosin Doxazosin Method Pharmaceuticals, LLC ANDA Current 58657-823 Doxazosin Doxazosin Method Pharmaceuticals, LLC ANDA Current