Home Applications 071785 Application 071785
Type ANDA
Sponsor CHARTWELL MOLECULES Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.3MG No No 002 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.1MG No No 003 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET;ORAL 0.2MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071785-001 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1988-04-05 A071785-002 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 1988-04-05 A071785-003 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 1988-04-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 129 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 2026-09-14 22:38:34 2026-08 A071785-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1988-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071785-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 1988-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071785-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 1988-04-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071785-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1988-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071785-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 1988-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071785-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 1988-04-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071785-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1988-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071785-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 1988-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071785-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 1988-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071785-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1988-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071785-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 1988-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071785-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 1988-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071785-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1988-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071785-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 1988-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071785-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 1988-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071785-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1988-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071785-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 1988-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071785-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 1988-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071785-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1988-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071785-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 1988-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071785-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 1988-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071785-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1988-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071785-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 1988-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071785-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 1988-04-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071785-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1988-04-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071785-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 1988-04-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071785-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 1988-04-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071785-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1988-04-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071785-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 1988-04-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071785-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 1988-04-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071785-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1988-04-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071785-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 1988-04-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071785-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 1988-04-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071785-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1988-04-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071785-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 1988-04-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071785-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 1988-04-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071785-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1988-04-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071785-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 1988-04-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071785-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 1988-04-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071785-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1988-04-05 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 87 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 6 · 113 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE REMEDYREPACK INC. 6d7cfb02-e580-4658-a2fe-2149b515d434 2026-09-09 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE REMEDYREPACK INC. 00c6d67a-bb11-4884-9eeb-4e1b8701a08b 2026-09-08 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE REMEDYREPACK INC. 4b889e12-0382-4679-9cec-d6829c59e853 2026-09-08 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE QLONILIK CLONIDINE HYDROCHLORIDE CMP Pharma, Inc. 826de1dc-378e-4c90-86d1-e33f7a4248cd 2026-08-12 Warnings, Adverse reactions Name fallback generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE Coupler LLC 58772b44-dec0-7001-e063-6394a90ac40e 2026-08-07 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE REMEDYREPACK INC. e5d24f52-e0c2-428d-b647-481d63ffd95f 2026-08-04 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE Redpharm Drug 53df40e7-dd2b-d40e-e063-6394a90a21c4 2026-07-31 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Major Pharmaceuticals 8171776a-dd14-4dcc-8860-3c27d8ea9504 2026-07-27 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE REMEDYREPACK INC. e96ab74c-eedf-4d71-8a35-d5ec3daa7592 2026-07-21 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE REMEDYREPACK INC. 574640a5-829d-4e9d-be32-832a48cbd8dd 2026-07-02 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE REMEDYREPACK INC. 2a183d05-5be7-43e9-a084-700ec05d01e9 2026-07-02 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE St. Mary's Medical Park Pharmacy 32d72d7b-5881-f431-e063-6394a90a3547 2026-06-26 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine hydrochloride CLONIDINE HYDROCHLORIDE Bryant Ranch Prepack cee049ea-a476-433c-971f-2466a6a3263b 2026-06-24 Warnings, Adverse reactions Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine hydrochloride CLONIDINE HYDROCHLORIDE Bryant Ranch Prepack f65d90dc-11b4-4d63-b4a9-30603bc332ea 2026-06-24 Warnings, Adverse reactions Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Unit Dose Solutions, Inc. 547beb0f-0c12-2ef4-e063-6394a90a6a73 2026-06-17 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine hydrochloride CLONIDINE HYDROCHLORIDE Unit Dose Solutions, Inc. 544ea5bf-6713-f034-e063-6394a90a781b 2026-06-15 Warnings, Adverse reactions Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE REMEDYREPACK INC. 7ec53e25-c50a-48b4-82b0-c0b3626f31dc 2026-06-01 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE PD-Rx Pharmaceuticals, Inc. ea1527a5-4939-4ff7-a827-f88a9113a07d 2026-05-26 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE PD-Rx Pharmaceuticals, Inc. be1b921d-152e-4bd5-82bd-56e2f8beef3e 2026-05-26 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE ASCLEMED USA INC. 200afa03-adf3-4dca-8de8-1569701bd029 2026-05-20 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.