Application 210647
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | SYRUP;ORAL | 2MG/5ML;10MG/5ML;30MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67877-558 | Brompheniramine, Pseudoephedrine, Dextromethorphan | Brompheniramine, Pseudoephedrine, Dextromethorphan | Ascend Laboratories, LLC | ANDA | Current |
| 67877-558 | Brompheniramine, Pseudoephedrine, Dextromethorphan | Brompheniramine, Pseudoephedrine, Dextromethorphan | Ascend Laboratories, LLC | ANDA | Current |