Home Applications 203167 Application 203167
Type ANDA
Sponsor XGEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE INJECTABLE;INJECTION 1MG/10ML (0.1MG/ML) No No 002 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE INJECTABLE;INJECTION 5MG/10ML (0.5MG/ML) 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 A203167-001 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 A203167-002 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29
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 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 3 · 82 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 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 39822-2000 Clonidine Clonidine X-GEN Pharmaceuticals, Inc. ANDA Current 39822-2000 Clonidine Clonidine XGen Pharmaceuticals DJB, Inc. ANDA Current 39822-2000 Clonidine Clonidine X-GEN Pharmaceuticals, Inc. ANDA Current 39822-2000 Clonidine Clonidine XGen Pharmaceuticals DJB, Inc. ANDA Current 39822-2000 Clonidine Clonidine XGen Pharmaceuticals DJB, Inc. ANDA Current 39822-2010 Clonidine Clonidine X-GEN Pharmaceuticals, Inc. ANDA Current 39822-2010 Clonidine Clonidine XGen Pharmaceuticals DJB, Inc. ANDA Current 39822-2010 Clonidine Clonidine X-GEN Pharmaceuticals, Inc. ANDA Current 39822-2010 Clonidine Clonidine XGen Pharmaceuticals DJB, Inc. ANDA Current 39822-2010 Clonidine Clonidine XGen Pharmaceuticals DJB, Inc. ANDA Current