Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078040
Company: ZYDUS PHARMS USA INC
Company: ZYDUS PHARMS USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RISPERIDONE | RISPERIDONE | 0.25MG | TABLET;ORAL | Prescription | AB | No | No |
| RISPERIDONE | RISPERIDONE | 0.5MG | TABLET;ORAL | Prescription | AB | No | No |
| RISPERIDONE | RISPERIDONE | 1MG | TABLET;ORAL | Prescription | AB | No | No |
| RISPERIDONE | RISPERIDONE | 2MG | TABLET;ORAL | Prescription | AB | No | No |
| RISPERIDONE | RISPERIDONE | 3MG | TABLET;ORAL | Prescription | AB | No | No |
| RISPERIDONE | RISPERIDONE | 4MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 10/16/2008 | 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 |
|---|---|---|---|---|---|
| 08/28/2020 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/28/2019 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/28/2019 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/28/2019 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/28/2019 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/25/2014 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/12/2012 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/11/2011 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/08/2011 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/29/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/12/2010 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
RISPERIDONE
TABLET;ORAL; 0.25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL | RISPERIDONE | 0.25MG | TABLET;ORAL | Prescription | Yes | AB | 020272 | JANSSEN PHARMS |
| RISPERIDONE | RISPERIDONE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 201003 | AJANTA PHARMA LTD |
| RISPERIDONE | RISPERIDONE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 078071 | AMNEAL |
| RISPERIDONE | RISPERIDONE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 077953 | APOTEX INC |
| RISPERIDONE | RISPERIDONE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 078871 | CELLTRION |
| RISPERIDONE | RISPERIDONE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 077543 | CHARTWELL MOLECULAR |
| RISPERIDONE | RISPERIDONE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 076879 | DR REDDYS LABS LTD |
| RISPERIDONE | RISPERIDONE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 077493 | PRINSTON INC |
| RISPERIDONE | RISPERIDONE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 078707 | RENATA |
| RISPERIDONE | RISPERIDONE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 078269 | RISING |
| RISPERIDONE | RISPERIDONE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 078528 | SANDOZ |
| RISPERIDONE | RISPERIDONE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 079088 | TORRENT PHARMS |
| RISPERIDONE | RISPERIDONE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 078040 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL | RISPERIDONE | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 020272 | JANSSEN PHARMS |
| RISPERIDONE | RISPERIDONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 201003 | AJANTA PHARMA LTD |
| RISPERIDONE | RISPERIDONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 078071 | AMNEAL |
| RISPERIDONE | RISPERIDONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 077953 | APOTEX INC |
| RISPERIDONE | RISPERIDONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 078871 | CELLTRION |
| RISPERIDONE | RISPERIDONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 077543 | CHARTWELL MOLECULAR |
| RISPERIDONE | RISPERIDONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 076879 | DR REDDYS LABS LTD |
| RISPERIDONE | RISPERIDONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 077493 | PRINSTON INC |
| RISPERIDONE | RISPERIDONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 078707 | RENATA |
| RISPERIDONE | RISPERIDONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 078269 | RISING |
| RISPERIDONE | RISPERIDONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 078528 | SANDOZ |
| RISPERIDONE | RISPERIDONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 079088 | TORRENT PHARMS |
| RISPERIDONE | RISPERIDONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 078040 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL | RISPERIDONE | 1MG | TABLET;ORAL | Prescription | Yes | AB | 020272 | JANSSEN PHARMS |
| RISPERIDONE | RISPERIDONE | 1MG | TABLET;ORAL | Prescription | No | AB | 201003 | AJANTA PHARMA LTD |
| RISPERIDONE | RISPERIDONE | 1MG | TABLET;ORAL | Prescription | No | AB | 078071 | AMNEAL |
| RISPERIDONE | RISPERIDONE | 1MG | TABLET;ORAL | Prescription | No | AB | 077953 | APOTEX INC |
| RISPERIDONE | RISPERIDONE | 1MG | TABLET;ORAL | Prescription | No | AB | 078871 | CELLTRION |
| RISPERIDONE | RISPERIDONE | 1MG | TABLET;ORAL | Prescription | No | AB | 077543 | CHARTWELL MOLECULAR |
| RISPERIDONE | RISPERIDONE | 1MG | TABLET;ORAL | Prescription | No | AB | 076879 | DR REDDYS LABS LTD |
| RISPERIDONE | RISPERIDONE | 1MG | TABLET;ORAL | Prescription | No | AB | 077493 | PRINSTON INC |
| RISPERIDONE | RISPERIDONE | 1MG | TABLET;ORAL | Prescription | No | AB | 078707 | RENATA |
| RISPERIDONE | RISPERIDONE | 1MG | TABLET;ORAL | Prescription | No | AB | 078269 | RISING |
| RISPERIDONE | RISPERIDONE | 1MG | TABLET;ORAL | Prescription | No | AB | 078528 | SANDOZ |
| RISPERIDONE | RISPERIDONE | 1MG | TABLET;ORAL | Prescription | No | AB | 079088 | TORRENT PHARMS |
| RISPERIDONE | RISPERIDONE | 1MG | TABLET;ORAL | Prescription | No | AB | 078040 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 2MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL | RISPERIDONE | 2MG | TABLET;ORAL | Prescription | Yes | AB | 020272 | JANSSEN PHARMS |
| RISPERIDONE | RISPERIDONE | 2MG | TABLET;ORAL | Prescription | No | AB | 201003 | AJANTA PHARMA LTD |
| RISPERIDONE | RISPERIDONE | 2MG | TABLET;ORAL | Prescription | No | AB | 078071 | AMNEAL |
| RISPERIDONE | RISPERIDONE | 2MG | TABLET;ORAL | Prescription | No | AB | 077953 | APOTEX INC |
| RISPERIDONE | RISPERIDONE | 2MG | TABLET;ORAL | Prescription | No | AB | 078871 | CELLTRION |
| RISPERIDONE | RISPERIDONE | 2MG | TABLET;ORAL | Prescription | No | AB | 077543 | CHARTWELL MOLECULAR |
| RISPERIDONE | RISPERIDONE | 2MG | TABLET;ORAL | Prescription | No | AB | 076879 | DR REDDYS LABS LTD |
| RISPERIDONE | RISPERIDONE | 2MG | TABLET;ORAL | Prescription | No | AB | 077493 | PRINSTON INC |
| RISPERIDONE | RISPERIDONE | 2MG | TABLET;ORAL | Prescription | No | AB | 078707 | RENATA |
| RISPERIDONE | RISPERIDONE | 2MG | TABLET;ORAL | Prescription | No | AB | 078269 | RISING |
| RISPERIDONE | RISPERIDONE | 2MG | TABLET;ORAL | Prescription | No | AB | 078528 | SANDOZ |
| RISPERIDONE | RISPERIDONE | 2MG | TABLET;ORAL | Prescription | No | AB | 079088 | TORRENT PHARMS |
| RISPERIDONE | RISPERIDONE | 2MG | TABLET;ORAL | Prescription | No | AB | 078040 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 3MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL | RISPERIDONE | 3MG | TABLET;ORAL | Prescription | Yes | AB | 020272 | JANSSEN PHARMS |
| RISPERIDONE | RISPERIDONE | 3MG | TABLET;ORAL | Prescription | No | AB | 201003 | AJANTA PHARMA LTD |
| RISPERIDONE | RISPERIDONE | 3MG | TABLET;ORAL | Prescription | No | AB | 078071 | AMNEAL |
| RISPERIDONE | RISPERIDONE | 3MG | TABLET;ORAL | Prescription | No | AB | 077953 | APOTEX INC |
| RISPERIDONE | RISPERIDONE | 3MG | TABLET;ORAL | Prescription | No | AB | 078871 | CELLTRION |
| RISPERIDONE | RISPERIDONE | 3MG | TABLET;ORAL | Prescription | No | AB | 077543 | CHARTWELL MOLECULAR |
| RISPERIDONE | RISPERIDONE | 3MG | TABLET;ORAL | Prescription | No | AB | 076879 | DR REDDYS LABS LTD |
| RISPERIDONE | RISPERIDONE | 3MG | TABLET;ORAL | Prescription | No | AB | 077493 | PRINSTON INC |
| RISPERIDONE | RISPERIDONE | 3MG | TABLET;ORAL | Prescription | No | AB | 078707 | RENATA |
| RISPERIDONE | RISPERIDONE | 3MG | TABLET;ORAL | Prescription | No | AB | 078269 | RISING |
| RISPERIDONE | RISPERIDONE | 3MG | TABLET;ORAL | Prescription | No | AB | 078528 | SANDOZ |
| RISPERIDONE | RISPERIDONE | 3MG | TABLET;ORAL | Prescription | No | AB | 079088 | TORRENT PHARMS |
| RISPERIDONE | RISPERIDONE | 3MG | TABLET;ORAL | Prescription | No | AB | 078040 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 4MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL | RISPERIDONE | 4MG | TABLET;ORAL | Prescription | Yes | AB | 020272 | JANSSEN PHARMS |
| RISPERIDONE | RISPERIDONE | 4MG | TABLET;ORAL | Prescription | No | AB | 201003 | AJANTA PHARMA LTD |
| RISPERIDONE | RISPERIDONE | 4MG | TABLET;ORAL | Prescription | No | AB | 078071 | AMNEAL |
| RISPERIDONE | RISPERIDONE | 4MG | TABLET;ORAL | Prescription | No | AB | 077953 | APOTEX INC |
| RISPERIDONE | RISPERIDONE | 4MG | TABLET;ORAL | Prescription | No | AB | 078871 | CELLTRION |
| RISPERIDONE | RISPERIDONE | 4MG | TABLET;ORAL | Prescription | No | AB | 077543 | CHARTWELL MOLECULAR |
| RISPERIDONE | RISPERIDONE | 4MG | TABLET;ORAL | Prescription | No | AB | 076879 | DR REDDYS LABS LTD |
| RISPERIDONE | RISPERIDONE | 4MG | TABLET;ORAL | Prescription | No | AB | 077493 | PRINSTON INC |
| RISPERIDONE | RISPERIDONE | 4MG | TABLET;ORAL | Prescription | No | AB | 078707 | RENATA |
| RISPERIDONE | RISPERIDONE | 4MG | TABLET;ORAL | Prescription | No | AB | 078269 | RISING |
| RISPERIDONE | RISPERIDONE | 4MG | TABLET;ORAL | Prescription | No | AB | 078528 | SANDOZ |
| RISPERIDONE | RISPERIDONE | 4MG | TABLET;ORAL | Prescription | No | AB | 079088 | TORRENT PHARMS |
| RISPERIDONE | RISPERIDONE | 4MG | TABLET;ORAL | Prescription | No | AB | 078040 | ZYDUS PHARMS USA INC |