Application 000793
- Type
- NDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | BUTISOL SODIUM | BUTABARBITAL SODIUM | TABLET;ORAL | 15MG | No | No |
| 003 | BUTISOL SODIUM | BUTABARBITAL SODIUM | TABLET;ORAL | 50MG | No | No |
| 004 | BUTISOL SODIUM | BUTABARBITAL SODIUM | TABLET;ORAL | 30MG | Yes | Yes |
| 005 | BUTISOL SODIUM | BUTABARBITAL SODIUM | TABLET;ORAL | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0037-0113 | Butisol Sodium | Butabarbital Sodium | Meda Pharmaceuticals | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57594 | SUPPL | 2019-02-14 |
| 57473 | SUPPL | 2019-02-07 |
| 32916 | SUPPL | 2007-10-04 |
| 45 | SUPPL | 2007-10-04 |
| 43991 | ORIG | 2007-03-16 |