Application 079170
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | 5MG | No | No |
| 002 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | 10MG | No | No |
| 003 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | 20MG | No | No |
| 004 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | 40MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43353-332 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-339 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-352 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-2447 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-2447 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-2449 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-2449 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-2449 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-2449 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-2451 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-2451 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-2451 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-2451 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-4710 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-4710 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-4710 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 52343-151 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-151 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | LUCID PHARMA LLC | ANDA | Current |
| 52343-152 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-152 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | LUCID PHARMA LLC | ANDA | Current |
| 52343-153 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-153 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | LUCID PHARMA LLC | ANDA | Current |
| 52343-154 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-154 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | LUCID PHARMA LLC | ANDA | Current |
| 53217-295 | Rosuvastatin Calcium | Rosuvastatin Calcium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53217-296 | Rosuvastatin Calcium | Rosuvastatin Calcium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53217-297 | Rosuvastatin Calcium | Rosuvastatin Calcium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 57237-168 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-168 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-168 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-168 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-168 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-168 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-168 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-169 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-169 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-169 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-169 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-169 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-169 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-169 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-170 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-170 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-170 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-170 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-170 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-170 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-170 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-171 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-171 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-171 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-171 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-171 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-171 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 57237-171 | Rosuvastatin Calcium | Rosuvastatin Calcium | Rising Health, LLC | ANDA | Current |
| 60687-234 | Rosuvastatin Calcium | Rosuvastatin Calcium | American Health Packaging | ANDA | Current |
| 60687-234 | Rosuvastatin Calcium | Rosuvastatin Calcium | American Health Packaging | ANDA | Current |
| 60687-234 | Rosuvastatin Calcium | Rosuvastatin Calcium | American Health Packaging | ANDA | Current |
| 60687-234 | Rosuvastatin Calcium | Rosuvastatin Calcium | American Health Packaging | ANDA | Current |
| 60687-245 | Rosuvastatin Calcium | Rosuvastatin Calcium | American Health Packaging | ANDA | Current |
| 60687-245 | Rosuvastatin Calcium | Rosuvastatin Calcium | American Health Packaging | ANDA | Current |
| 60687-245 | Rosuvastatin Calcium | Rosuvastatin Calcium | American Health Packaging | ANDA | Current |
| 60687-245 | Rosuvastatin Calcium | Rosuvastatin Calcium | American Health Packaging | ANDA | Current |
| 60687-256 | Rosuvastatin Calcium | Rosuvastatin Calcium | American Health Packaging | ANDA | Current |
| 60687-256 | Rosuvastatin Calcium | Rosuvastatin Calcium | American Health Packaging | ANDA | Current |
| 60687-256 | Rosuvastatin Calcium | Rosuvastatin Calcium | American Health Packaging | ANDA | Current |
| 60687-256 | Rosuvastatin Calcium | Rosuvastatin Calcium | American Health Packaging | ANDA | Current |
| 63187-860 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-860 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-860 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-860 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-864 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-864 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-864 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-864 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-865 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-865 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-865 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-865 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 63187-872 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9232 | ORIG | 2016-07-20 |
| 31421 | ORIG | 2010-05-17 |