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Application 209869
- Type
- ANDA
- Sponsor
- CHARTWELL RX
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | TABLET;ORAL | 10MG | No | No |
| 002 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | TABLET;ORAL | 20MG | No | No |
| 003 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | TABLET;ORAL | 40MG | No | No |
| 004 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | TABLET;ORAL | 80MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55801-141 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | APPCO PHARMA LLC | ANDA | Current |
| 55801-142 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | APPCO PHARMA LLC | ANDA | Current |
| 55801-143 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | APPCO PHARMA LLC | ANDA | Current |
| 55801-144 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | APPCO PHARMA LLC | ANDA | Current |
| 63629-8904 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-8904 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-8905 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-8905 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-8906 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-8906 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-8909 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-8909 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-8910 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-8910 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-8911 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-8911 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-8912 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-8912 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-8913 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-8913 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-9162 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-9162 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-9163 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-9163 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-9164 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-9164 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-9165 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 63629-9165 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | Bryant Ranch Prepack | ANDA | Current |
| 70377-045 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | BIOCON PHARMA INC., | ANDA | Current |
| 70377-045 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | BIOCON PHARMA INC., | ANDA | Current |
| 70377-046 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | BIOCON PHARMA INC., | ANDA | Current |
| 70377-046 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | BIOCON PHARMA INC., | ANDA | Current |
| 70377-047 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | BIOCON PHARMA INC., | ANDA | Current |
| 70377-047 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | BIOCON PHARMA INC., | ANDA | Current |
| 70377-048 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | BIOCON PHARMA INC., | ANDA | Current |
| 70377-048 | PRAVASTATIN SODIUM | PRAVASTATIN SODIUM | BIOCON PHARMA INC., | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 53693 | ORIG | 2018-04-16 |