Application 077752
- Type
- ANDA
- Sponsor
- DR REDDYS LABS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 10MG | No | No |
| 002 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 20MG | No | No |
| 003 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 40MG | No | No |
| 004 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 80MG | No | No |
| 005 | SIMVASTATIN | SIMVASTATIN | TABLET;ORAL | 5MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-6579 | Simvastatin | Simvastatin | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-6580 | Simvastatin | Simvastatin | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-6581 | Simvastatin | Simvastatin | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-6588 | Simvastatin | Simvastatin | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-5800 | Simvastatin | Simvastatin | Major Pharmaceuticals | ANDA | Current |
| 0904-5802 | Simvastatin | Simvastatin | Major Pharmaceuticals | ANDA | Current |
| 43063-080 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-080 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-080 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-080 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-080 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-162 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-162 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-162 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-162 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-162 | Simvastatin | Simvastatin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55111-198 | Simvastatin | Simvastatin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-199 | Simvastatin | Simvastatin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-200 | Simvastatin | Simvastatin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-268 | Simvastatin | Simvastatin | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55700-223 | Simvastatin | Simvastatin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 67046-671 | Simvastatin | Simvastatin | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-674 | Simvastatin | Simvastatin | Contract Pharmacy Services-PA | ANDA | Current |
| 68645-261 | Simvastatin | Simvastatin | Legacy Pharmaceutical Packaging | ANDA | Current |
| 68645-262 | Simvastatin | Simvastatin | Legacy Pharmaceutical Packaging | ANDA | Current |
| 68645-263 | Simvastatin | Simvastatin | Legacy Pharmaceutical Packaging | ANDA | Current |
| 68788-9835 | Simvastatin | Simvastatin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9836 | Simvastatin | Simvastatin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 75921-200 | Simvastatin | Simvastatin | Life Line Home Care Services, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23886 | ORIG | 2011-05-26 |