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 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.
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