Application 216211
- Type
- ANDA
- Sponsor
- RUBICON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | TABLET;ORAL | 25MG;37.5MG | No | No |
| 002 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | TABLET;ORAL | 50MG;75MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72888-094 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Advagen Pharma Ltd | ANDA | Current |
| 72888-095 | Triamterene and Hydrochlorothiazide | Triamterene and Hydrochlorothiazide | Advagen Pharma Ltd | ANDA | Current |