Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202520
Company: PHARMOBEDIENT
Company: PHARMOBEDIENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POLMON | DEXCHLORPHENIRAMINE MALEATE | 2MG/5ML | SYRUP;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 07/16/2018 | ORIG-1 | Approval |
Label is not available on this site. |
POLMON
SYRUP;ORAL; 2MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POLMON | DEXCHLORPHENIRAMINE MALEATE | 2MG/5ML | SYRUP;ORAL | Prescription | No | AA | 202520 | PHARMOBEDIENT |