Home Applications 070317 Application 070317
Type ANDA
Sponsor MYLAN 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 A070317-001 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 A070317-002 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 A070317-003 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09
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 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 301d65b070ca…
Observed Orange Book normalized TE history# 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 6 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 Alembic Pharmaceuticals Limited 88a8db46-0fc9-48cd-b7cc-ac9c9cdea100 2023-01-27 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine hydrochloride CLONIDINE HYDROCHLORIDE Asclemed USA, Inc. e8c7aa08-1450-de68-e053-2995a90ad0b6 2022-09-16 Warnings, Adverse reactions Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine hydrochloride CLONIDINE HYDROCHLORIDE Proficient Rx LP 33c68d5e-6a68-40fd-a326-bf36a7e01d5b 2022-09-01 Warnings, Adverse reactions Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Actavis Pharma, Inc. a842ab83-3531-44dd-a8a8-64dd89e87026 2022-09-01 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE Proficient Rx LP 38680c1d-3929-40d5-bda9-4eea5693afca 2022-08-01 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. 2a5b46ec-4c16-48a5-9e58-8d28a3f21274 2022-06-27 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Aurobindo Pharma Limited 2b75c20c-9dcc-4a63-854a-e9cdd2d7c1fb 2022-06-08 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE Duraclon CLONIDINE HYDROCHLORIDE Mylan Institutional LLC 8c126bb8-732a-4949-8754-2f50b5543638 2021-03-17 Boxed warning, Warnings, Adverse reactions Name fallback generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Xiamen LP Pharmaceutical Co., Ltd. 7676af27-4d8f-49c4-a50f-6b0892e73c8f 2020-10-27 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE Asclemed USA, Inc. b60034a6-b8ba-4e54-9ef0-029965e67bc0 2020-10-24 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine hydrochloride CLONIDINE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 00d1562d-b4eb-4d89-95de-0aacee7a82a5 2020-07-29 Warnings, Adverse reactions Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE Proficient Rx LP c812012c-4b1d-40a4-8d4e-aaae2bf1c852 2019-10-01 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC e9b22c56-a3fc-46df-b745-11c4ac309a91 2017-05-03 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 33 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-0152 Clonidine Hydrochloride clonidine hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 0378-0152 Clonidine Hydrochloride clonidine hydrochloride Mylan Pharmaceuticals Inc ANDA Current 0378-0186 Clonidine Hydrochloride clonidine hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 0378-0186 Clonidine Hydrochloride clonidine hydrochloride Mylan Pharmaceuticals Inc ANDA Current 0378-0199 Clonidine Hydrochloride clonidine hydrochloride Mylan Pharmaceuticals Inc. ANDA Current 0378-0199 Clonidine Hydrochloride clonidine hydrochloride Mylan Pharmaceuticals Inc ANDA Current 43063-190 Clonidine Hydrochloride clonidine hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-190 Clonidine Hydrochloride clonidine hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current 43063-190 Clonidine Hydrochloride clonidine hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current 51079-299 Clonidine Hydrochloride clonidine hydrochloride Mylan Institutional Inc. ANDA Current 51079-299 Clonidine Hydrochloride clonidine hydrochloride Mylan Institutional Inc. ANDA Current 51079-299 Clonidine Hydrochloride clonidine hydrochloride Mylan Institutional Inc. ANDA Current 51079-300 Clonidine Hydrochloride clonidine hydrochloride Mylan Institutional Inc. ANDA Current 51079-300 Clonidine Hydrochloride clonidine hydrochloride Mylan Institutional Inc. ANDA Current 51079-300 Clonidine Hydrochloride clonidine hydrochloride Mylan Institutional Inc. ANDA Current 51079-301 Clonidine Hydrochloride clonidine hydrochloride Mylan Institutional Inc. ANDA Current 51079-301 Clonidine Hydrochloride clonidine hydrochloride Mylan Institutional Inc. ANDA Current 51079-301 Clonidine Hydrochloride clonidine hydrochloride Mylan Institutional Inc. ANDA Current 51662-1515 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst ANDA Current 52584-094 CLONIDINE HYDROCHLORIDE clonidine hydrochloride General Injectables & Vaccines, Inc. ANDA Current 52584-094 CLONIDINE HYDROCHLORIDE clonidine hydrochloride General Injectables & Vaccines, Inc. ANDA Current 52584-094 CLONIDINE HYDROCHLORIDE clonidine hydrochloride General Injectables & Vaccines, Inc. ANDA Current 53808-0228 Clonidine Hydrochloride Clonidine Hydrochloride State of Florida DOH Central Pharmacy ANDA Current 53808-0230 Clonidine Hydrochloride Clonidine Hydrochloride State of Florida DOH Central Pharmacy ANDA Current 55154-5561 Clonidine Hydrochloride Clonidine Hydrochloride Cardinal Health ANDA Current 55154-5562 Clonidine Hydrochloride Clonidine Hydrochloride Cardinal Health ANDA Current 55154-5570 Clonidine Hydrochloride Clonidine Hydrochloride Cardinal Health ANDA Current 55154-6297 Clonidine Hydrochloride Clonidine Hydrochloride Cardinal Health ANDA Current 55289-073 Clonidine Hydrochloride clonidine hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-074 Clonidine Hydrochloride clonidine hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-970 Clonidine Hydrochloride clonidine hydrochloride PD-Rx Pharmaceuticals, Inc. ANDA Current 67046-098 Clonidine Hydrochloride Clonidine Hydrochloride Contract Pharmacy Services-PA ANDA Current 70518-1837 Clonidine Hydrochloride clonidine hydrochloride REMEDYREPACK INC. ANDA Current