Application 209008
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PSEUDOEPHEDRINE HYDROCHLORIDE | PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 120MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 58602-804 | Pseudoephedrine HCl | Pseudoephedrine HCl | Aurohealth LLC | ANDA | Current |
| 58602-804 | Pseudoephedrine HCl | Pseudoephedrine HCl | Aurohealth LLC | ANDA | Current |
| 58602-804 | Pseudoephedrine HCl | Pseudoephedrine HCl | Aurohealth LLC | ANDA | Current |