Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040829
Company: AVANTHI INC
Company: AVANTHI INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORPHENIRAMINE MALEATE | CHLORPHENIRAMINE MALEATE | 12MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/13/2009 | ORIG-1 | Approval |
Label is not available on this site. |
CHLORPHENIRAMINE MALEATE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, EXTENDED RELEASE;ORAL; 12MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHLORPHENIRAMINE MALEATE | CHLORPHENIRAMINE MALEATE | 12MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 040829 | AVANTHI INC |