Application 211694
- Type
- ANDA
- Sponsor
- NOVITIUM PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | SYRUP;ORAL | 60MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66689-406 | Pyridostigmine Bromide | Pyridostigmine Bromide | VistaPharm, Inc. | ANDA | Current |
| 66689-406 | Pyridostigmine Bromide | Pyridostigmine Bromide | VistaPharm, Inc. | ANDA | Current |
| 70954-148 | Pyridostigmine | Pyridostigmine bromide oral | Novitium Pharma LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57967 | ORIG | 2019-03-12 |