Home Applications 201951 Application 201951
Type ANDA
Sponsor ACTAVIS ELIZABETH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE TABLET;ORAL EQ 3MG BASE No No 002 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE TABLET;ORAL EQ 6MG 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201951-001 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 A201951-002 DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 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 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL 2013-07-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL 2013-07-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201951-001 DOXEPIN HYDROCHLORIDE EQ 3MG BASE TABLET / ORAL AB 2013-07-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A201951-002 DOXEPIN HYDROCHLORIDE EQ 6MG BASE TABLET / ORAL AB 2013-07-26 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 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.
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 0228-3315 Doxepin Doxepin Actavis Pharma, Inc. ANDA Current 0228-3315 Doxepin Doxepin Actavis Pharma, Inc. ANDA Current 0228-3315 Doxepin Doxepin Actavis Pharma, Inc. ANDA Current 0228-3316 Doxepin Doxepin Actavis Pharma, Inc. ANDA Current 0228-3316 Doxepin Doxepin Actavis Pharma, Inc. ANDA Current 0228-3316 Doxepin Doxepin Actavis Pharma, Inc. ANDA Current 70518-3495 Doxepin Doxepin REMEDYREPACK INC. ANDA Current