Product NDC: | 10702-005 |
Proprietary Name: | Dexbrompherniramine Maleate and Pseudoephedrine Sulfate |
Non Proprietary Name: | Dexbrompherniramine Maleate and Pseudoephedrine Sulfate |
Active Ingredient(s): | 6; 120 mg/1; mg/1 & nbsp; Dexbrompherniramine Maleate and Pseudoephedrine Sulfate |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 10702-005 |
Labeler Name: | KVK-TECH, INC. |
Product Type: | HUMAN OTC DRUG |
FDA Application Number: | ANDA078648 |
Marketing Category: | ANDA |
Start Marketing Date: | 20130227 |
Package NDC: | 10702-005-03 |
Package Description: | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10702-005-03) |
NDC Code | 10702-005-03 |
Proprietary Name | Dexbrompherniramine Maleate and Pseudoephedrine Sulfate |
Package Description | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10702-005-03) |
Product NDC | 10702-005 |
Product Type Name | HUMAN OTC DRUG |
Non Proprietary Name | Dexbrompherniramine Maleate and Pseudoephedrine Sulfate |
Dosage Form Name | TABLET, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20130227 |
Marketing Category Name | ANDA |
Labeler Name | KVK-TECH, INC. |
Substance Name | DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE |
Strength Number | 6; 120 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes |