Application 089096
- Type
- ANDA
- Sponsor
- ODYSSEY PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | URECHOLINE | BETHANECHOL CHLORIDE | TABLET;ORAL | 50MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50111-326 | Bethanechol Chloride | Bethanechol Chloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 50111-326 | Bethanechol Chloride | Bethanechol Chloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 51285-692 | Urecholine | Bethanechol Chloride | Teva Women's Health, Inc. | ANDA | Current |
| 51285-692 | Urecholine | Bethanechol Chloride | Teva Women's Health, Inc. | ANDA | Current |
| 51285-692 | Urecholine | Bethanechol Chloride | Teva Women's Health, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22696 | ORIG | 2005-07-22 |