Application 086101
- Type
- ANDA
- Sponsor
- VALEANT PHARMS NORTH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SECONAL SODIUM | SECOBARBITAL SODIUM | CAPSULE;ORAL | 50MG | No | Yes |
| 002 | SECONAL SODIUM | SECOBARBITAL SODIUM | CAPSULE;ORAL | 100MG | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0187-4220 | Seconal Sodium | secobarbital sodium | Bausch Health US, LLC | ANDA | Current |
| 0187-4220 | Seconal Sodium | secobarbital sodium | Valeant Pharmaceuticals North America LLC | ANDA | Current |
| 0187-4220 | Seconal Sodium | secobarbital sodium | Valeant Pharmaceuticals North America LLC | ANDA | Current |
| 0187-4220 | Seconal Sodium | secobarbital sodium | Bausch Health US, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23932 | ORIG | 2007-03-16 |