Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202386
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RISPERIDONE | RISPERIDONE | 1MG/ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
01/12/2015 | ORIG-1 | Approval |
Label is not available on this site. |
RISPERIDONE
SOLUTION;ORAL; 1MG/ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RISPERDAL | RISPERIDONE | 1MG/ML | SOLUTION;ORAL | Prescription | Yes | AA | 020588 | JANSSEN PHARMS |
RISPERIDONE | RISPERIDONE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 091384 | AMNEAL PHARMS |
RISPERIDONE | RISPERIDONE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 078452 | AUROBINDO PHARMA LTD |
RISPERIDONE | RISPERIDONE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 202386 | CHARTWELL MOLECULAR |
RISPERIDONE | RISPERIDONE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 079158 | LANNETT CO INC |
RISPERIDONE | RISPERIDONE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 090347 | TARO |
RISPERIDONE | RISPERIDONE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 079059 | TRIS PHARMA INC |