Application 215910
- Type
- NDA
- Sponsor
- SUN PHARMA ADVANCED RESEARCH COMPANY, LTD.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SEZABY | PHENOBARBITAL | SOLUTION; INJECTION | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62756-301 | SEZABY | phenobarbital sodium | Sun Pharmaceutical Industries, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 75115 | ORIG | 2023-08-18 |
| 73615 | ORIG | 2023-02-27 |
| 72653 | ORIG | 2022-11-18 |