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 4 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 Bryant Ranch Prepack 029ed62c-67cb-406f-84e4-702aebfa7d68 2025-03-21 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Bryant Ranch Prepack 74b40ae9-a9d7-443e-8d7a-80362ec5be6d 2025-03-21 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Bryant Ranch Prepack 6c95c495-f630-45c1-92c3-8c0fdb22013c 2025-03-21 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. df4b087e-a81a-1321-e053-2995a90a2b9f 2025-03-19 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Somerset Therapeutics, LLC 1b4fb182-8194-4fdd-bf9b-f7e60e734179 2025-03-07 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Method Pharmaceuticals, LLC dffb5fdd-06c0-4275-9f89-9e12b3adf8a9 2025-02-21 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE PD-Rx Pharmaceuticals, Inc. 5366a055-47fd-41eb-81d8-ffb3be1dc38c 2025-02-05 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. 7cd64137-09d7-7a00-e053-2a91aa0a06ae 2025-01-17 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE AvPAK fcebe343-18ad-d4cd-e053-6294a90a72d5 2025-01-09 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE A-S Medication Solutions 329382fb-ccf8-488d-a0b2-68ff959a0846 2024-12-20 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE A-S Medication Solutions aecd05bf-e7ba-4cab-9494-4ce3bbd1aa99 2024-12-20 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Bryant Ranch Prepack d3b099db-698e-4ea8-a6df-42dc79234597 2024-11-08 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE A-S Medication Solutions c5c85b76-4d5c-47f0-bafb-31efe1fbaed3 2024-10-09 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE A-S Medication Solutions 9d889b1c-9599-44fa-9e47-6261fbf2837e 2024-10-09 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE A-S Medication Solutions c7f473df-94ab-41db-8cc7-9a159d5e6dc4 2024-10-08 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Bryant Ranch Prepack 0f8adf88-26a4-4dd1-bfbb-784a528641e6 2024-10-04 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Bryant Ranch Prepack 1c65bafb-9752-4785-84b1-376cf863fd07 2024-09-18 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE A-S Medication Solutions 70c0c9f4-075d-4621-ae13-e8f03d814d5f 2024-09-05 Warnings, Adverse reactions Name fallback brand name: clonidine hydrochloride generic name: CLONIDINE HYDROCHLORIDE Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE Bryant Ranch Prepack 1df79865-c028-45c7-8580-9908eec80979 2024-08-27 Warnings, Adverse reactions Name fallback brand name: Clonidine Hydrochloride generic name: CLONIDINE HYDROCHLORIDE clonidine hydrochloride CLONIDINE HYDROCHLORIDE Bryant Ranch Prepack be6c29cd-1692-4dd3-868e-7efcb3a85056 2024-08-23 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