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Application 075468
- Type
- ANDA
- Sponsor
- RUBICON
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CLONAZEPAM | CLONAZEPAM | TABLET;ORAL | 0.5MG | No | No |
| 002 | CLONAZEPAM | CLONAZEPAM | TABLET;ORAL | 1MG | No | No |
| 003 | CLONAZEPAM | CLONAZEPAM | TABLET;ORAL | 2MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 72888-152 | Clonazepam | Clonazepam | Advagen Pharma Ltd | ANDA | Current |
| 72888-153 | Clonazepam | Clonazepam | Advagen Pharma Ltd | ANDA | Current |
| 72888-154 | Clonazepam | Clonazepam | Advagen Pharma Ltd | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 30897 | ORIG | 2000-10-06 |