Application 018891

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CATAPRES-TTS-1	CLONIDINE	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/24HR	Yes	No
002	CATAPRES-TTS-2	CLONIDINE	FILM, EXTENDED RELEASE;TRANSDERMAL	0.2MG/24HR	Yes	No
003	CATAPRES-TTS-3	CLONIDINE	FILM, EXTENDED RELEASE;TRANSDERMAL	0.3MG/24HR	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N018891-001	CATAPRES-TTS-1	CLONIDINE	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10
N018891-002	CATAPRES-TTS-2	CLONIDINE	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10
N018891-003	CATAPRES-TTS-3	CLONIDINE	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	1984-10-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N018891-001	AB
N018891-002	AB
N018891-003	AB

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 2 of 4 · 132 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018891-002	CATAPRES-TTS-2	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018891-003	CATAPRES-TTS-3	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	1984-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018891-001	CATAPRES-TTS-1	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018891-002	CATAPRES-TTS-2	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018891-003	CATAPRES-TTS-3	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	1984-10-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018891-001	CATAPRES-TTS-1	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018891-002	CATAPRES-TTS-2	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018891-003	CATAPRES-TTS-3	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	1984-10-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018891-001	CATAPRES-TTS-1	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018891-002	CATAPRES-TTS-2	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018891-003	CATAPRES-TTS-3	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	1984-10-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018891-001	CATAPRES-TTS-1	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018891-002	CATAPRES-TTS-2	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018891-003	CATAPRES-TTS-3	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	1984-10-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018891-001	CATAPRES-TTS-1	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018891-002	CATAPRES-TTS-2	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018891-003	CATAPRES-TTS-3	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	1984-10-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018891-001	CATAPRES-TTS-1	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018891-002	CATAPRES-TTS-2	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018891-003	CATAPRES-TTS-3	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	1984-10-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018891-001	CATAPRES-TTS-1	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	1984-10-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018891-002	CATAPRES-TTS-2	0.2MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	1984-10-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018891-003	CATAPRES-TTS-3	0.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	1984-10-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018891-001	CATAPRES-TTS-1	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018891-002	CATAPRES-TTS-2	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018891-003	CATAPRES-TTS-3	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	1984-10-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018891-001	CATAPRES-TTS-1	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018891-002	CATAPRES-TTS-2	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018891-003	CATAPRES-TTS-3	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	1984-10-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018891-001	CATAPRES-TTS-1	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018891-002	CATAPRES-TTS-2	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018891-003	CATAPRES-TTS-3	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	1984-10-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018891-001	CATAPRES-TTS-1	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018891-002	CATAPRES-TTS-2	0.2MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD	1984-10-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018891-003	CATAPRES-TTS-3	0.3MG/24HR	SYSTEM / TRANSDERMAL	AB	RLD, RS	1984-10-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018891-001	CATAPRES-TTS-1	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	1984-10-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018891-002	CATAPRES-TTS-2	0.2MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	1984-10-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018891-003	CATAPRES-TTS-3	0.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	1984-10-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018891-001	CATAPRES-TTS-1	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	1984-10-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018891-002	CATAPRES-TTS-2	0.2MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	1984-10-10	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N018891-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018891-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018891-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018891-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018891-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018891-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018891-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018891-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018891-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018891-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018891-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018891-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018891-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018891-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018891-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018891-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018891-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018891-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018891-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018891-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018891-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018891-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018891-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018891-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018891-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018891-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018891-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018891-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018891-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018891-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018891-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018891-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018891-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018891-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018891-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018891-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018891-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018891-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018891-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018891-001	AB	1	`79d66fd596c7…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonidine Transdermal System USP, 0.1 mg/day	CLONIDINE TRANSDERMAL SYSTEM	TruPharma, LLC	0fcfcdb5-0662-41d9-919b-c66d4f4f0c8b	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018891 application number: NDA018891
Catapres-TTS-1	CLONIDINE TRANSDERMAL SYSTEM	Technomed Inc.	39e1d35e-533c-4647-8649-8168a6e92dfa	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018891 application number: NDA018891

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 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0031	Catapres-TTS	clonidine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0031	Catapres-TTS	clonidine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0031	Catapres-TTS	clonidine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0031	Catapres-TTS	clonidine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0032	Catapres-TTS	clonidine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0032	Catapres-TTS	clonidine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0032	Catapres-TTS	clonidine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0032	Catapres-TTS	clonidine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0033	Catapres-TTS	clonidine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0033	Catapres-TTS	clonidine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0033	Catapres-TTS	clonidine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0033	Catapres-TTS	clonidine	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
21695-567	Catapres	clonidine	Rebel Distributors Corp	NDA	Current
82089-101	Catapres-TTS-1	clonidine	Technomed Inc.	NDA	Current
82089-101	Catapres-TTS-1	clonidine	Technomed Inc.	NDA	Current
82089-102	Catapres-TTS-2	clonidine	Technomed Inc.	NDA	Current
82089-102	Catapres-TTS-2	clonidine	Technomed Inc.	NDA	Current
82089-103	Catapres-TTS-3	clonidine	Technomed Inc.	NDA	Current
82089-103	Catapres-TTS-3	clonidine	Technomed Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73380	SUPPL	2023-02-06
73376	SUPPL	2023-02-03
73370	SUPPL	2023-02-02
16084	SUPPL	2012-06-07
11358	SUPPL	2012-06-06
33636	SUPPL	2010-05-07
16083	SUPPL	2010-05-03
1119	SUPPL	2010-01-07
11357	SUPPL	2009-11-13
16082	SUPPL	2006-04-14
1118	SUPPL	2004-08-25
20162	SUPPL	2003-08-05