Application 075137
- Type
- ANDA
- Sponsor
- PHARM ASSOC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | SYRUP;ORAL | 5MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0121-0671 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | Pharmaceutical Associates, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8534 | ORIG | 1998-12-18 |