Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077328
Company: DR REDDYS LABS LTD
Company: DR REDDYS LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/24/2009 | ORIG-1 | Approval |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077328ls000lb.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/20/2012 | SUPPL-10 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/30/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/25/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/26/2011 | SUPPL-7 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/09/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/27/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/29/2010 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2009 | SUPPL-3 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 10/05/2009 | SUPPL-2 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 08/24/2009 | SUPPL-1 | Labeling-Patient Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/24/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077328ls000lb.pdf |
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 | 090839 | JUBILANT GENERICS |
| RISPERIDONE | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077494 | PAR PHARM |
| 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 | 090839 | JUBILANT GENERICS |
| RISPERIDONE | RISPERIDONE | 1MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077494 | PAR PHARM |
| 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 | 090839 | JUBILANT GENERICS |
| RISPERIDONE | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077494 | PAR PHARM |
| 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 | 090839 | JUBILANT GENERICS |
| RISPERIDONE | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077494 | PAR PHARM |
| 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 | 090839 | JUBILANT GENERICS |
| RISPERIDONE | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077494 | PAR PHARM |
| 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 |