Details for New Drug Application (NDA): 040458
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The generic ingredient in CARBINOXAMINE MALEATE is carbinoxamine maleate. There are seven drug master file entries for this compound. Eight 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 |
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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