Home Applications 074145 Application 074145
Type ANDA
Sponsor WATSON LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE No No 002 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE TABLET;ORAL EQ 2MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A074145-001 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 A074145-002 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17
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 · 84 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 2026-08-18 06:07:40 2026-07 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0591-0444 Guanfacine Guanfacine Actavis Pharma, Inc. ANDA Current 0591-0444 Guanfacine Guanfacine Actavis Pharma, Inc. ANDA Current 0591-0453 Guanfacine Guanfacine Actavis Pharma, Inc. ANDA Current 0591-0453 Guanfacine Guanfacine Actavis Pharma, Inc. ANDA Current 68151-0623 Guanfacine Guanfacine Carilion Materials Management ANDA Current 70518-1369 Guanfacine Guanfacine REMEDYREPACK INC. ANDA Current 70518-1369 Guanfacine Guanfacine REMEDYREPACK INC. ANDA Current 70518-1369 Guanfacine Guanfacine REMEDYREPACK INC. ANDA Current 70518-1369 Guanfacine Guanfacine REMEDYREPACK INC. ANDA Current 70518-1369 Guanfacine Guanfacine REMEDYREPACK INC. ANDA Current 70518-1371 Guanfacine Guanfacine REMEDYREPACK INC. ANDA Current 70518-1371 Guanfacine Guanfacine REMEDYREPACK INC. ANDA Current 70518-1371 Guanfacine Guanfacine REMEDYREPACK INC. ANDA Current 70518-1371 Guanfacine Guanfacine REMEDYREPACK INC. ANDA Current