Application 089424
- Type
- ANDA
- Sponsor
- SUN PHARM INDUSTRIES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SPIRONOLACTONE | SPIRONOLACTONE | TABLET;ORAL | 25MG | No | No |
| 002 | SPIRONOLACTONE | SPIRONOLACTONE | TABLET;ORAL | 50MG | No | No |
| 003 | SPIRONOLACTONE | SPIRONOLACTONE | TABLET;ORAL | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-084 | SPIRONOLACTONE | SPIRONOLACTONE | NorthStar Rx LLC | ANDA | Current |
| 16714-084 | SPIRONOLACTONE | SPIRONOLACTONE | NorthStar Rx LLC | ANDA | Current |
| 16714-085 | SPIRONOLACTONE | SPIRONOLACTONE | NorthStar Rx LLC | ANDA | Current |
| 16714-085 | SPIRONOLACTONE | SPIRONOLACTONE | NorthStar Rx LLC | ANDA | Current |
| 16714-086 | SPIRONOLACTONE | SPIRONOLACTONE | NorthStar Rx LLC | ANDA | Current |
| 16714-086 | SPIRONOLACTONE | SPIRONOLACTONE | NorthStar Rx LLC | ANDA | Current |
| 21695-766 | Spironolactone | spironolactone | Rebel Distributors Corp | ANDA | Current |
| 50090-0136 | Spironolactone | spironolactone | A-S Medication Solutions | ANDA | Current |
| 50090-0136 | Spironolactone | spironolactone | A-S Medication Solutions | ANDA | Current |
| 50436-4477 | Spironolactone | spironolactone | Unit Dose Services | ANDA | Current |
| 50436-5015 | Spironolactone | spironolactone | Unit Dose Services | ANDA | Current |
| 50436-9973 | Spironolactone | spironolactone | Unit Dose Services | ANDA | Current |
| 53489-143 | SPIRONOLACTONE | SPIRONOLACTONE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-143 | Spironolactone | spironolactone | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-143 | SPIRONOLACTONE | SPIRONOLACTONE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-143 | SPIRONOLACTONE | SPIRONOLACTONE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-328 | SPIRONOLACTONE | SPIRONOLACTONE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-328 | Spironolactone | spironolactone | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-328 | SPIRONOLACTONE | SPIRONOLACTONE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-328 | SPIRONOLACTONE | SPIRONOLACTONE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-329 | SPIRONOLACTONE | SPIRONOLACTONE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-329 | Spironolactone | spironolactone | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-329 | SPIRONOLACTONE | SPIRONOLACTONE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-329 | SPIRONOLACTONE | SPIRONOLACTONE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63629-1061 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1061 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1061 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1061 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1061 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1061 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1062 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1062 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1062 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1062 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1062 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1062 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1063 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1063 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1063 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1064 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1064 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1064 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1064 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1064 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1064 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1064 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1064 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1065 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1065 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1065 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1065 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1065 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1065 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1066 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1066 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1066 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1066 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1066 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1066 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1067 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1067 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1067 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1067 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1067 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1067 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1067 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1067 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1067 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1092 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1092 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1092 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1092 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1092 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1093 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1093 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1093 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1093 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1093 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1094 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1094 | SPIRONOLACTONE | SPIRONOLACTONE | Bryant Ranch Prepack | ANDA | Current |