Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075565
Company: PHARM ASSOC
Company: PHARM ASSOC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LORATADINE | LORATADINE | 1MG/ML | SYRUP;ORAL | Discontinued | None | No | No |
| LORATADINE | LORATADINE | 5MG/5ML | SYRUP; ORAL | Over-the-counter | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/05/2004 | ORIG-1 | Approval |
Label is not available on this site. |
LORATADINE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SYRUP; ORAL; 5MG/5ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| LORATADINE | LORATADINE | 5MG/5ML | SYRUP; ORAL | Over-the-counter | No | 075565 | PHARM ASSOC |