Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091188
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 0.5MG/5ML | ELIXIR;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
05/11/2011 | ORIG-1 | Approval |
Label is not available on this site. |
DEXAMETHASONE
ELIXIR;ORAL; 0.5MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 0.5MG/5ML | ELIXIR;ORAL | Prescription | No | AA | 084754 | ANIMA |
DEXAMETHASONE | DEXAMETHASONE | 0.5MG/5ML | ELIXIR;ORAL | Prescription | No | AA | 091188 | CHARTWELL MOLECULAR |
DEXAMETHASONE | DEXAMETHASONE | 0.5MG/5ML | ELIXIR;ORAL | Prescription | No | AA | 090891 | LYNE |