Details for New Drug Application (NDA): 207484
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NDA 207484 describes CARBINOXAMINE MALEATE, which is a drug marketed by Cypress Pharm, Endo Operations, Genus, 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. Eight 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. Eight suppliers are listed for this compound. Additional details are available on the carbinoxamine maleate profile page.
Summary for 207484
| Tradename: | CARBINOXAMINE MALEATE |
| Applicant: | Mikart |
| Ingredient: | carbinoxamine maleate |
| Patents: | 0 |
Pharmacology for NDA: 207484
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 207484
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBINOXAMINE MALEATE | carbinoxamine maleate | TABLET;ORAL | 207484 | ANDA | Carwin Pharmaceutical Associates, LLC | 15370-130 | 15370-130-02 | 2 TABLET in 1 BOTTLE, PLASTIC (15370-130-02) |
| CARBINOXAMINE MALEATE | carbinoxamine maleate | TABLET;ORAL | 207484 | ANDA | Carwin Pharmaceutical Associates, LLC | 15370-130 | 15370-130-10 | 100 TABLET in 1 BOTTLE, PLASTIC (15370-130-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6MG | ||||
| Approval Date: | May 31, 2016 | TE: | RLD: | No | |||||
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