Application 020615

Type: NDA
Sponsor: MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DURACLON	CLONIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	1MG/10ML (0.1MG/ML)	Yes	No
002	DURACLON	CLONIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	5MG/10ML (0.5MG/ML)	Yes	Yes

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
N020615-001	DURACLON	CLONIDINE HYDROCHLORIDE	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02
N020615-002	DURACLON	CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020615-001	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020615-002	DURACLON	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020615-002	DURACLON	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020615-002	DURACLON	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020615-002	DURACLON	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020615-002	DURACLON	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020615-002	DURACLON	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020615-002	DURACLON	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020615-002	DURACLON	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020615-002	DURACLON	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020615-002	DURACLON	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020615-002	DURACLON	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020615-002	DURACLON	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020615-002	DURACLON	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020615-002	DURACLON	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020615-002	DURACLON	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020615-002	DURACLON	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1999-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020615-002	DURACLON	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION		RLD	1999-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020615-002	DURACLON	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION		RLD	1999-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020615-002	DURACLON	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION		RLD	1999-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020615-001	DURACLON	1MG/10ML (0.1MG/ML)	INJECTABLE / INJECTION	AP	RLD	1996-10-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020615-002	DURACLON	5MG/10ML (0.5MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1999-04-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 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	N020615-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020615-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020615-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020615-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020615-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020615-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020615-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020615-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020615-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020615-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020615-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020615-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020615-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020615-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020615-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020615-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020615-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020615-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020615-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020615-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020615-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020615-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020615-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020615-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020615-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020615-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020615-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020615-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020615-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020615-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020615-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020615-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020615-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020615-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020615-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020615-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020615-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020615-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020615-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020615-001	AP	1	`a72a2bbeb626…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duraclon	CLONIDINE HYDROCHLORIDE	Mylan Institutional LLC	8c126bb8-732a-4949-8754-2f50b5543638	2021-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020615 application number: NDA020615 ndc (product): 67457-218

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67457-218	Duraclon	clonidine hydrochloride	Mylan Institutional LLC	NDA	Current
67457-218	Duraclon	clonidine hydrochloride	Mylan Institutional LLC	NDA	Current
67457-218	Duraclon	clonidine hydrochloride	Mylan Institutional LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
12851	SUPPL	2010-08-09
25325	SUPPL	2010-08-02
12850	SUPPL	2009-05-13
25324	SUPPL	2009-05-04
41482	ORIG	1996-11-04