Application 202357
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | 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 |
|---|
| 0615-7772 | Atorvastatin Calcium | Atorvastatin Calcium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 55111-124 | Atorvastatin Calcium | Atorvastatin Calcium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-124 | Atorvastatin Calcium | Atorvastatin Calcium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-124 | Atorvastatin Calcium | Atorvastatin Calcium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-124 | Atorvastatin Calcium | Atorvastatin Calcium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-124 | Atorvastatin Calcium | Atorvastatin Calcium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-124 | Atorvastatin Calcium | Atorvastatin Calcium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-124 | Atorvastatin Calcium | Atorvastatin Calcium | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 63739-037 | Atorvastatin Calcium | Atorvastatin Calcium | Mckesson Corporation DBA SKY Packaginng | ANDA | Current |
| 63739-037 | Atorvastatin Calcium | Atorvastatin Calcium | Mckesson Corporation DBA SKY Packaginng | ANDA | Current |
| 63739-037 | Atorvastatin Calcium | Atorvastatin Calcium | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 68788-9983 | Atorvastatin Calcium | Atorvastatin Calcium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 43399 | ORIG | 2015-03-09 |