Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078909
Company: APOZEAL PHARMS
Company: APOZEAL PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 07/29/2009 | 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 |
|---|---|---|---|---|---|
| 05/28/2025 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/28/2025 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/28/2025 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/28/2025 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/28/2025 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/01/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/10/2011 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/10/2011 | SUPPL-7 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/10/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/11/2011 | SUPPL-2 | 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 | 076440 | ANI PHARMS |
| RISPERIDONE | RISPERIDONE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 078909 | APOZEAL 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 | 079059 | TRIS PHARMA INC |