Application 078979
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 125MG VALPROIC ACID | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-1393 | Divalproex sodium | Divalproex sodium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-1393 | Divalproex sodium | Divalproex sodium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8237 | Divalproex sodium | Divalproex sodium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8237 | Divalproex sodium | Divalproex sodium | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8237 | Divalproex sodium | Divalproex sodium | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0904-6615 | Divalproex sodium | Divalproex sodium | Major Pharmaceuticals | ANDA | Current |
| 0904-6615 | Divalproex sodium | Divalproex sodium | Major Pharmaceuticals | ANDA | Current |
| 0904-6615 | Divalproex sodium | Divalproex sodium | Major Pharmaceuticals | ANDA | Current |
| 0904-6615 | Divalproex sodium | Divalproex sodium | Major Pharmaceuticals | ANDA | Current |
| 55111-532 | Divalproex sodium | Divalproex sodium | Dr. Reddy's Laboratories | ANDA | Current |
| 55111-532 | Divalproex sodium | Divalproex sodium | Dr. Reddy's Laboratories Ltd | ANDA | Current |
| 55111-532 | Divalproex sodium | Divalproex sodium | Dr. Reddy's Laboratories Ltd | ANDA | Current |
| 55111-532 | Divalproex sodium | Divalproex sodium | Dr. Reddy's Laboratories Ltd | ANDA | Current |
| 55111-532 | Divalproex sodium | Divalproex sodium | Dr. Reddy's Laboratories Ltd | ANDA | Current |
| 55111-532 | Divalproex sodium | Divalproex sodium | Dr. Reddy's Laboratories Ltd | ANDA | Current |
| 55111-532 | Divalproex sodium | Divalproex sodium | Dr. Reddy's Laboratories Ltd | ANDA | Current |
| 55154-3552 | Divalproex sodium | Divalproex sodium | Cardinal Health | ANDA | Current |
| 63739-995 | Divalproex sodium | Divalproex sodium | McKesson Corporation dba SKY Packaging | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31400 | ORIG | 2009-01-27 |