Application 022556
- Type
- NDA
- Sponsor
- AYTU
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KARBINAL ER | CARBINOXAMINE MALEATE | SUSPENSION, EXTENDED RELEASE;ORAL | 4MG/5ML | Yes | Yes |
Orange Book products#
| 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022556-001 | KARBINAL ER | 4MG/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2013-03-28 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N022556-001 | KARBINAL ER | 4MG/5ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2013-03-28 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N022556-001 | 9522191 | 2027-06-15 | Drug product | 2016-12-22 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N022556-001 | 8062667 | 2029-03-29 | Drug product | 2013-04-18 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N022556-001 | 9522191 | 2027-06-15 | Drug product | 2016-12-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022556-001 | 8062667 | 2029-03-29 | Drug product | 2013-04-18 | 84e616aacf4f… | |
| 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… |
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.
| 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 | 022556 NDA022556 23594-101 |
| Carbinoxamine Maleate Extended-Release Oral Suspension | CARBINOXAMINE MALEATE | Neos Therapeutics, LP | 199f46e5-6288-5627-e063-6294a90ae086 | 2026-03-12 | Warnings, Adverse reactions | 022556 NDA022556 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| 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 |