Application 214390
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYANOCOBALAMIN | CYANOCOBALAMIN | INJECTABLE;INJECTION | 1MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68083-449 | Cyanocobalamin | Cyanocobalamin | Gland Pharma Limited | ANDA | Current |
| 68083-449 | Cyanocobalamin | Cyanocobalamin | Gland Pharma Limited | ANDA | Current |
| 68083-449 | Cyanocobalamin | Cyanocobalamin | Gland Pharma Limited | ANDA | Current |
| 68083-561 | cyanocobalamin | cyanocobalamin | Gland Pharma Limited | ANDA | Current |
| 68083-562 | cyanocobalamin | cyanocobalamin | Gland Pharma Limited | ANDA | Current |
| 71288-303 | Cyanocobalamin | Cyanocobalamin | Meitheal Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72360 | SUPPL | 2022-10-17 |