Application 214864
- Type
- ANDA
- Sponsor
- NOVITIUM PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BETAINE | BETAINE | FOR SOLUTION;ORAL | 1GM/SCOOPFUL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0713-0352 | Betaine | Betaine | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 70954-331 | Betaine Anhydrous | Betaine Anhydrous | Novitium Pharma LLC | ANDA | Current |
| 72647-900 | Betaine Anhydrous for Oral Solution | Betaine Anhydrous | OAKRUM PHARMA, LLC | ANDA | Current |
| 72647-900 | Betaine Anhydrous for Oral Solution | Betaine Anhydrous | OAKRUM PHARMA, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69692 | ORIG | 2021-12-20 |