Application 078648
- Type
- ANDA
- Sponsor
- AVANTHI INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE | DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE | TABLET, EXTENDED RELEASE;ORAL | 6MG;120MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078648-001 | DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE | DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE | 6MG;120MG | TABLET, EXTENDED RELEASE / ORAL | 2013-02-27 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10702-005 | Dexbrompherniramine Maleate and Pseudoephedrine Sulfate | Dexbrompherniramine Maleate and Pseudoephedrine Sulfate | KVK-TECH, INC. | ANDA | Current |