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Application 075521
- Type
- ANDA
- Sponsor
- RUBICON
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No |
| 004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 7.5MG | No | No |
| 005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70518-3428 | busPIRone HCl | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 72888-062 | busPIRone HCl | buspirone hydrochloride | Advagen Pharma Ltd | ANDA | Current |
| 72888-063 | busPIRone HCl | buspirone hydrochloride | Advagen Pharma Ltd | ANDA | Current |
| 72888-064 | busPIRone HCl | buspirone hydrochloride | Advagen Pharma Ltd | ANDA | Current |
| 72888-065 | busPIRone HCl | buspirone hydrochloride | Advagen Pharma Ltd | ANDA | Current |
| 72888-066 | busPIRone HCl | buspirone hydrochloride | Advagen Pharma Ltd | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8706 | ORIG | 2004-05-28 |
| 8707 | ORIG | 2003-04-10 |