Details for New Drug Application (NDA): 040458
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NDA 040458 describes CARBINOXAMINE MALEATE, which is a drug marketed by Cypress Pharm, Genus, Vintage Pharms, Invagen Pharms, Mikart, Mission Pharmacal, and Strides Pharma, and is included in nine NDAs. It is available from six suppliers. Additional details are available on the CARBINOXAMINE MALEATE profile page.
The generic ingredient in CARBINOXAMINE MALEATE is carbinoxamine maleate. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the carbinoxamine maleate profile page.
The generic ingredient in CARBINOXAMINE MALEATE is carbinoxamine maleate. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the carbinoxamine maleate profile page.
Summary for 040458
| Tradename: | CARBINOXAMINE MALEATE |
| Applicant: | Genus |
| Ingredient: | carbinoxamine maleate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040458
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 040458
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBINOXAMINE MALEATE | carbinoxamine maleate | SOLUTION;ORAL | 040458 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-334 | 51991-334-04 | 118 mL in 1 BOTTLE, PLASTIC (51991-334-04) |
| CARBINOXAMINE MALEATE | carbinoxamine maleate | SOLUTION;ORAL | 040458 | ANDA | Genus Lifesciences Inc. | 64950-243 | 64950-243-04 | 118 mL in 1 BOTTLE, PLASTIC (64950-243-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 4MG/5ML | ||||
| Approval Date: | Apr 25, 2003 | TE: | RLD: | No | |||||
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