Application 076154
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LORATADINE | LORATADINE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-8880 | Loratadine | loratadine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 51079-246 | Loratadine | loratadine | Mylan Institutional Inc. | ANDA | Current |
| 51079-246 | Loratadine | loratadine | Mylan Institutional Inc. | ANDA | Current |
| 55154-4375 | Loratadine | loratadine | Cardinal Health 107, LLC | ANDA | Current |
| 55154-4375 | Loratadine | loratadine | Cardinal Health | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8871 | ORIG | 2003-04-11 |