Application 213853
- Type
- ANDA
- Sponsor
- UMEDICA LABS PVT LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 10MG BASE | No | No |
| 002 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 20MG BASE | No | No |
| 003 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 40MG BASE | No | No |
| 004 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | TABLET;ORAL | EQ 80MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 68788-8298 | Atorvastatin calcium | Atorvastatin calcium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 72189-291 | ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | DirectRX | ANDA | Current |
| 75834-255 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-255 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-255 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-255 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-255 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-255 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-256 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-256 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-256 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-256 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-256 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-256 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-257 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-257 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-257 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-257 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-257 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-257 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-258 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-258 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-258 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-258 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-258 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-258 | Atorvastatin calcium | Atorvastatin calcium | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |