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.

Application-product, TE code table
Application-product	TE code
A202601-001	AP
A202601-002	AP

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202601-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202601-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202601-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202601-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202601-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202601-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202601-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202601-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202601-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202601-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202601-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202601-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202601-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202601-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202601-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202601-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202601-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202601-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202601-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202601-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202601-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202601-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202601-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202601-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202601-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202601-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202601-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202601-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202601-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202601-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202601-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202601-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202601-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202601-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202601-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202601-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202601-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202601-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202601-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202601-002	AP	1	`74a2ff9319b5…`

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 · 109 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 · 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