Application 076739
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 10MG;12.5MG | No | No |
| 002 | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 20MG;12.5MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63304-403 | Fosinopril Sodium and Hydrochlorothiazide | Fosinopril Sodium and Hydrochlorothiazide | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-404 | Fosinopril Sodium and Hydrochlorothiazide | Fosinopril Sodium and Hydrochlorothiazide | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |