Application 210717
- Type
- ANDA
- Sponsor
- BIONPHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG | No | No |
| 002 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG | No | No |
| 003 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 15MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69452-119 | Oxybutynin Chloride | Oxybutynin Chloride | Bionpharma Inc. | ANDA | Current |
| 69452-119 | Oxybutynin Chloride | Oxybutynin Chloride | Bionpharma Inc. | ANDA | Current |
| 69452-119 | Oxybutynin Chloride | Oxybutynin Chloride | Bionpharma Inc. | ANDA | Current |
| 69452-120 | Oxybutynin Chloride | Oxybutynin Chloride | Bionpharma Inc. | ANDA | Current |
| 69452-120 | Oxybutynin Chloride | Oxybutynin Chloride | Bionpharma Inc. | ANDA | Current |
| 69452-120 | Oxybutynin Chloride | Oxybutynin Chloride | Bionpharma Inc. | ANDA | Current |
| 69452-121 | Oxybutynin Chloride | Oxybutynin Chloride | Bionpharma Inc. | ANDA | Current |
| 69452-121 | Oxybutynin Chloride | Oxybutynin Chloride | Bionpharma Inc. | ANDA | Current |
| 69452-121 | Oxybutynin Chloride | Oxybutynin Chloride | Bionpharma Inc. | ANDA | Current |