Application 212795
- Type
- ANDA
- Sponsor
- TENSHI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LORATADINE | LORATADINE | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51316-502 | LORATADINE | LORATADINE | CVS PHARMACY, INC | ANDA | Current |
| 57483-955 | Allervarx | Loratadine | Innovus Pharmaceuticals, Inc. | ANDA | Current |
| 59556-301 | LORATADINE | LORATADINE | Strides Pharma Inc | ANDA | Current |
| 59556-301 | LORATADINE | LORATADINE | Strides Pharma Inc | ANDA | Current |
| 59556-301 | LORATADINE | LORATADINE | Strides Pharma Inc | ANDA | Current |
| 72983-500 | Loratadine | Loratadine | Tenshi Kaizen Pvt Ltd | ANDA | Current |
| 72983-500 | Loratadine | Loratadine | Tenshi Kaizen Pvt Ltd | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 65101 | ORIG | 2020-10-30 |