Application 089095
- Type
- ANDA
- Sponsor
- ODYSSEY PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | URECHOLINE | BETHANECHOL CHLORIDE | TABLET;ORAL | 5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50111-323 | Bethanechol Chloride | Bethanechol Chloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 50111-323 | Bethanechol Chloride | Bethanechol Chloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 51285-697 | Urecholine | Bethanechol Chloride | Teva Women's Health, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 43219 | ORIG | 2007-04-09 |