Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079158
Company: LANNETT CO INC
Company: LANNETT CO INC
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 |
---|---|---|---|---|---|---|---|
12/03/2010 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/12/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
10/22/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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01/30/2012 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
11/04/2011 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/26/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
04/20/2011 | SUPPL-1 | Labeling-Package Insert, Labeling-Package Insert |
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 |