carbinoxamine Oral Solution
- Brand(s)
- Arbinoxa
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Breckenridge Pharmaceutical, Inc. (2015-10-31)
- Oldest Current Product
- 2003-04-25
- License(s)
- ANDA
- RxNORM
- ORAL SOLUTION\CARBINOXAMINE
- FDAOB
- ORAL\SOLUTION\CARBINOXAMINE MALEATE
- SPL Active
- ORAL\SOLUTION\CARBINOXAMINE MALEATE
ORAL\SYRUP\CARBINOXAMINE MALEATE - SPL Moiety
- ORAL\SOLUTION\CARBINOXAMINE
ORAL\SYRUP\CARBINOXAMINE
product(s) by strength(s)
carbinoxamine maleate 0.8 mg/ml oral solution
original product(s)(s)
| # | id | labeler | active ingredient(s) | route | dose form | spl |
|---|---|---|---|---|---|---|
| 1 | 519910334 | Breckenridge Pharmaceutical, Inc. | CARBINOXAMINE MALEATE | ORAL | SYRUP | 1edca669-8879-408a-b09c-259e363dd95c |
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 466720644 | ANDA | Mikart, Inc. | 2003-04-25 | CARBINOXAMINE MALEATE | ORAL | SYRUP | ANDA040458 | 748c233b-6ab9-42d0-89ab-e7ead30f7947 | |
| 2 | 637170871 | Arbinoxa | ANDA | Hawthorn Pharmaceutical, Inc. | 2011-04-01 | CARBINOXAMINE MALEATE | ORAL | SOLUTION | ANDA090418 | 040d6792-21fe-44cc-a441-b9693178b3b5 |
| 3 | 643760612 | ANDA | Boca Pharmacal, Llc | 2008-02-26 | CARBINOXAMINE MALEATE | ORAL | SOLUTION | ANDA040814 | 1741b4f2-af49-43fe-8319-7b8a38fa25d2 |
application(s)
| # | id | title | applicant | approved | approved drug |
|---|---|---|---|---|---|
| 1 | ANDA040458 | CARBINOXAMINE MALEATE | MIKART INC | 2003-04-25 | ANDA040458_001 |
| 2 | ANDA040814 | CARBINOXAMINE MALEATE | VINTAGE PHARMACEUTICALS | 2008-02-26 | ANDA040814_001 |
| 3 | ANDA090418 | CARBINOXAMINE MALEATE | CYPRESS PHARMACEUTICAL INC | 2010-05-04 | ANDA090418_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA040458_001 | RX | CARBINOXAMINE MALEATE (4MG/5ML) | ORAL | SOLUTION | True | AA | 2003-04-25 | CARBINOXAMINE MALEATE |
| 2 | ANDA040814_001 | RX | CARBINOXAMINE MALEATE (4MG/5ML) | ORAL | SOLUTION | False | AA | 2008-02-26 | CARBINOXAMINE MALEATE |
| 3 | ANDA090418_001 | RX | CARBINOXAMINE MALEATE (4MG/5ML) | ORAL | SOLUTION | False | AA | 2010-05-04 | CARBINOXAMINE MALEATE |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 040d6792-21fe-44cc-a441-b9693178b3b5 (view SPL) | Arbinoxa (Carbinoxamine Maleate) Oral Solution [Hawthorn Pharmaceuticals, Inc] Rx only | prescription | Human Prescription | Hawthorn Pharmaceutical, Inc. | 2012-06-15 | 3 | 637170871 | |
| 2 | 1741b4f2-af49-43fe-8319-7b8a38fa25d2 (view SPL) | Carbinoxamine Maleate Tablets USP, 4mg | prescription | Human Prescription | Boca Pharmacal, Llc | 2013-09-10 | 3 | 643760612, 643760605 | carbinoxamine Oral Tablet |
| 3 | 1edca669-8879-408a-b09c-259e363dd95c (view SPL) | prescription | Human Prescription | Breckenridge Pharmaceutical, Inc. | 2015-10-31 | 2 | 519910334, 519910333 | carbinoxamine Oral Tablet | |
| 4 | 748c233b-6ab9-42d0-89ab-e7ead30f7947 (view SPL) | prescription | Human Prescription | Mikart, Inc. | 2015-08-10 | 1 | 466720644, 466720191 | carbinoxamine Oral Tablet |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII