Home Applications 202601 Application 202601
Type ANDA
Sponsor ZYDUS 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 43 .
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 A202601-001 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 A202601-002 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20
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 · 86 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 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 3 of 6 · 109 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clonidine hydrochloride CLONIDINE HYDROCHLORIDE Northwind Health Company, LLC f30324be-47b6-7f54-e053-2995a90a3ad4 2026-01-01 Warnings, Adverse reactions Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine hydrochloride CLONIDINE HYDROCHLORIDE Northwind Health Company, LLC df77e732-9765-ee5c-e053-2a95a90abc92 2026-01-01 Warnings, Adverse reactions Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Northwind Health Company, LLC 18c873b1-f2fe-4ba9-b384-38e917af373b 2026-01-01 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE BluePoint Laboratories 1ea412db-d847-4094-be83-e3bd7328537a 2025-11-04 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE VERITYRX, LLC 42788adf-a54d-3545-e063-6394a90a8c69 2025-10-31 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE VERITYRX, LLC 427939a4-6bbf-0d80-e063-6294a90aa2a0 2025-10-31 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine hydrochloride CLONIDINE HYDROCHLORIDE Ajanta Pharma USA Inc. df80255e-f942-4d9f-8edd-cc95795772cb 2025-10-31 Warnings, Adverse reactions Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Bryant Ranch Prepack 60171b1d-03af-4849-a030-6260192b11ce 2025-10-29 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE Proficient Rx LP d072d601-b3d2-46e0-af1f-98adc9572f4a 2025-10-01 Warnings, Adverse reactions Name fallback brand name: CLONIDINE HYDROCHLORIDE generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Bryant Ranch Prepack 5bc6188d-5b51-4dee-a12d-f2d5e42eb88d 2025-09-18 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE Redpharm Drug 300b4437-74b3-119b-e063-6394a90a0d0f 2025-08-30 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine hydrochloride CLONIDINE HYDROCHLORIDE BluePoint Laboratories f34ae077-4ace-4e0a-bc87-d559b1c5bf2f 2025-08-19 Warnings, Adverse reactions Name fallback brand name: Clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. 746dcdfd-7dfb-4a29-e053-2991aa0a8a4c 2025-05-07 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE ONYDA XR CLONIDINE HYDROCHLORIDE NextWave Pharmaceuticals, Inc 4a15c850-9da5-4bdc-a34d-7f740a6149b7 2025-04-11 Warnings, Adverse reactions Name fallback generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Coupler LLC 325f382b-6c04-2608-e063-6394a90a3872 2025-04-09 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Bryant Ranch Prepack 122f6904-bb63-42c5-b000-f4f5c75586cc 2025-04-01 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Bryant Ranch Prepack d2f80661-34c4-42ff-b1c2-3ab8f9d9ef4d 2025-04-01 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Bryant Ranch Prepack 075b6261-9064-41da-b5e0-0959767e0d9a 2025-03-31 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE Bryant Ranch Prepack 100a31f2-9a8e-4245-a09c-05583c3244c3 2025-03-31 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE Bryant Ranch Prepack 1c13555e-acfc-4a3a-93cd-e6f012f36c61 2025-03-28 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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68382-601 clonidine hydrochloride clonidine hydrochloride Zydus Pharmaceuticals USA Inc. ANDA Current 68382-601 clonidine hydrochloride clonidine hydrochloride Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-601 clonidine hydrochloride clonidine hydrochloride Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-602 clonidine hydrochloride clonidine hydrochloride Zydus Pharmaceuticals USA Inc. ANDA Current 68382-602 clonidine hydrochloride clonidine hydrochloride Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-602 clonidine hydrochloride clonidine hydrochloride Zydus Pharmaceuticals (USA) Inc. ANDA Current 70771-1193 clonidine hydrochloride clonidine hydrochloride Cadila Healthcare Limited ANDA Current 70771-1193 clonidine hydrochloride clonidine hydrochloride Zydus Lifesciences Limited ANDA Current 70771-1193 clonidine hydrochloride clonidine hydrochloride Cadila Healthcare Limited ANDA Current 70771-1193 clonidine hydrochloride clonidine hydrochloride Cadila Healthcare Limited ANDA Current 70771-1194 clonidine hydrochloride clonidine hydrochloride Cadila Healthcare Limited ANDA Current 70771-1194 clonidine hydrochloride clonidine hydrochloride Zydus Lifesciences Limited ANDA Current 70771-1194 clonidine hydrochloride clonidine hydrochloride Cadila Healthcare Limited ANDA Current 70771-1194 clonidine hydrochloride clonidine hydrochloride Cadila Healthcare Limited ANDA Current