Application 022556

Type: NDA
Sponsor: AYTU

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KARBINAL ER	CARBINOXAMINE MALEATE	SUSPENSION, EXTENDED RELEASE;ORAL	4MG/5ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022556-001	KARBINAL ER	CARBINOXAMINE MALEATE	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2013-03-28

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022556-001	9522191	2027-06-15		Drug product	2016-12-22
N022556-001	8062667	2029-03-29		Drug product	2013-04-18

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022556-001	KARBINAL ER	4MG/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2013-03-28	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022556-001	9522191	2027-06-15	Drug product	2016-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022556-001	8062667	2029-03-29	Drug product	2013-04-18	`bb7c543d1eb4…`

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
Karbinal ER	CARBINOXAMINE MALEATE	Aytu Therapeutics, LLC	c40b3f4e-2d71-41a1-a1fc-f64f38724879	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022556 application number: NDA022556 ndc (product): 23594-101
Carbinoxamine Maleate Extended-Release Oral Suspension	CARBINOXAMINE MALEATE	Neos Therapeutics, LP	199f46e5-6288-5627-e063-6294a90ae086	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022556 application number: NDA022556

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23594-101	Karbinal	Carbinoxamine Maleate	Zylera Pharmaceuticals, L	NDA	Current
23594-101	Karbinal	Carbinoxamine Maleate	Aytu Therapeutics, LLC	NDA	Current
23594-101	Karbinal	Carbinoxamine Maleate	Aytu Therapeutics, LLC	NDA	Current
23594-101	Karbinal	Carbinoxamine Maleate	Cerecor, Inc.	NDA	Current
23594-101	Karbinal	Carbinoxamine Maleate	Aytu Therapeutics, LLC	NDA	Current
23594-101	Karbinal	Carbinoxamine Maleate	Aytu Therapeutics, LLC	NDA	Current
23594-101	Karbinal	Carbinoxamine Maleate	Aytu Therapeutics, LLC	NDA	Current
23594-101	Karbinal	Carbinoxamine Maleate	Aytu Therapeutics, LLC	NDA	Current
23594-101	Karbinal	Carbinoxamine Maleate	Aytu Therapeutics, LLC	NDA	Current
23594-101	Karbinal	Carbinoxamine Maleate	Aytu Therapeutics, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85329	SUPPL	2026-03-12
85328	SUPPL	2026-03-12
66889	SUPPL	2021-03-26
66884	SUPPL	2021-03-26
24339	ORIG	2014-06-24
22055	ORIG	2014-06-24
17704	ORIG	2013-04-01
7528	ORIG	2013-04-01
52408	ORIG	1900-01-01
52407	ORIG	1900-01-01