Home Applications 203018 Application 203018
Type ANDA
Sponsor SCIEGEN PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 25MG No No 002 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET;ORAL 50MG 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 A203018-001 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 A203018-002 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23
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 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203018-001 HYDROCHLOROTHIAZIDE 25MG TABLET / ORAL AB 2014-07-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203018-002 HYDROCHLOROTHIAZIDE 50MG TABLET / ORAL AB 2014-07-23 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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50228-111 Hydrochlorothiazide Hydrochlorothiazide ScieGen Pharmaceuticals, Inc. ANDA Current 50228-111 Hydrochlorothiazide Hydrochlorothiazide ScieGen Pharmaceuticals, Inc. ANDA Current 50228-111 Hydrochlorothiazide Hydrochlorothiazide ScieGen Pharmaceuticals, Inc. ANDA Current 50228-112 Hydrochlorothiazide Hydrochlorothiazide ScieGen Pharmaceuticals, Inc. ANDA Current 50228-112 Hydrochlorothiazide Hydrochlorothiazide ScieGen Pharmaceuticals, Inc. ANDA Current 50228-112 Hydrochlorothiazide Hydrochlorothiazide ScieGen Pharmaceuticals, Inc. ANDA Current 60429-214 Hydrochlorothiazide Hydrochlorothiazide Golden State Medical Supply, Inc ANDA Current 60429-215 Hydrochlorothiazide Hydrochlorothiazide Golden State Medical Supply, Inc ANDA Current 69367-122 Hydrochlorothiazide Hydrochlorothiazide Westminster Pharmaceuticals, LLC ANDA Current 69367-122 Hydrochlorothiazide Hydrochlorothiazide Westminster Pharmaceuticals, LLC ANDA Current 69367-123 Hydrochlorothiazide Hydrochlorothiazide Westminster Pharmaceuticals, LLC ANDA Current 69367-123 Hydrochlorothiazide Hydrochlorothiazide Westminster Pharmaceuticals, LLC ANDA Current