Details for New Drug Application (NDA): 078648
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NDA 078648 describes DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE, which is a drug marketed by Avanthi Inc and is included in one NDA. It is available from one supplier. Additional details are available on the DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE profile page.
The generic ingredient in DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE is dexbrompheniramine maleate; pseudoephedrine sulfate. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dexbrompheniramine maleate; pseudoephedrine sulfate profile page.
The generic ingredient in DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE is dexbrompheniramine maleate; pseudoephedrine sulfate. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dexbrompheniramine maleate; pseudoephedrine sulfate profile page.
Summary for 078648
| Tradename: | DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE |
| Applicant: | Avanthi Inc |
| Ingredient: | dexbrompheniramine maleate; pseudoephedrine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 078648
| Mechanism of Action | Adrenergic alpha-Agonists |
Suppliers and Packaging for NDA: 078648
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE | dexbrompheniramine maleate; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 078648 | ANDA | KVK-TECH, INC. | 10702-005 | 10702-005-03 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10702-005-03) |
| DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE | dexbrompheniramine maleate; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 078648 | ANDA | KVK-TECH, INC. | 10702-005 | 10702-005-21 | 2 BLISTER PACK in 1 CARTON (10702-005-21) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 6MG;120MG | ||||
| Approval Date: | Feb 27, 2013 | TE: | RLD: | No | |||||
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