Drugs@FDA: FDA-Approved Drugs
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RISPERIDONE | RISPERIDONE | 0.25MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | None | No | No |
RISPERIDONE | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
RISPERIDONE | RISPERIDONE | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
RISPERIDONE | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
RISPERIDONE | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
RISPERIDONE | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
RISPERIDONE | RISPERIDONE | 1MG | TABLET, ORALLY DISINTEGRATING; ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
04/30/2009 | 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 |
---|---|---|---|---|---|
08/31/2022 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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08/31/2022 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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12/09/2019 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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12/09/2019 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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09/22/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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08/30/2013 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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04/10/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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02/21/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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05/27/2011 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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12/29/2010 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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10/26/2009 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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10/19/2009 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
RISPERIDONE
TABLET, ORALLY DISINTEGRATING;ORAL; 0.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077328 | DR REDDYS LABS LTD |
RISPERIDONE | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077494 | ENDO OPERATIONS |
RISPERIDONE | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090839 | JUBILANT GENERICS |
RISPERIDONE | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078116 | SANDOZ |
RISPERIDONE | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077542 | SUN PHARM INDS LTD |
RISPERIDONE | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078464 | SUN PHARM INDS LTD |
RISPERIDONE | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078516 | ZYDUS PHARMS USA |
TABLET, ORALLY DISINTEGRATING;ORAL; 1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | RISPERIDONE | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077328 | DR REDDYS LABS LTD |
RISPERIDONE | RISPERIDONE | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077494 | ENDO OPERATIONS |
RISPERIDONE | RISPERIDONE | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090839 | JUBILANT GENERICS |
RISPERIDONE | RISPERIDONE | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078116 | SANDOZ |
RISPERIDONE | RISPERIDONE | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077542 | SUN PHARM INDS LTD |
RISPERIDONE | RISPERIDONE | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078464 | SUN PHARM INDS LTD |
TABLET, ORALLY DISINTEGRATING;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077328 | DR REDDYS LABS LTD |
RISPERIDONE | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077494 | ENDO OPERATIONS |
RISPERIDONE | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090839 | JUBILANT GENERICS |
RISPERIDONE | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078116 | SANDOZ |
RISPERIDONE | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077542 | SUN PHARM INDS LTD |
RISPERIDONE | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078464 | SUN PHARM INDS LTD |
RISPERIDONE | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078516 | ZYDUS PHARMS USA |
TABLET, ORALLY DISINTEGRATING;ORAL; 3MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077328 | DR REDDYS LABS LTD |
RISPERIDONE | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077494 | ENDO OPERATIONS |
RISPERIDONE | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090839 | JUBILANT GENERICS |
RISPERIDONE | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078116 | SANDOZ |
RISPERIDONE | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078464 | SUN PHARM INDS LTD |
RISPERIDONE | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078474 | SUN PHARM INDS LTD |
TABLET, ORALLY DISINTEGRATING;ORAL; 4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077328 | DR REDDYS LABS LTD |
RISPERIDONE | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077494 | ENDO OPERATIONS |
RISPERIDONE | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090839 | JUBILANT GENERICS |
RISPERIDONE | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078116 | SANDOZ |
RISPERIDONE | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078464 | SUN PHARM INDS LTD |
RISPERIDONE | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078474 | SUN PHARM INDS LTD |