Application 211170
- Type
- ANDA
- Sponsor
- WES PHARMA INC
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 |
|---|---|---|---|---|---|
| 63739-723 | Brompheniramine maleate, pseudoephedrine hydrochloride, | Brompheniramine maleate, pseudoephedrine hydrochloride, | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 71930-026 | Brompheniramine maleate, pseudoephedrine hydrochloride, | Brompheniramine maleate, pseudoephedrine hydrochloride, | Eywa Pharma Inc | ANDA | Current |