Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078071
Company: AMNEAL
Company: AMNEAL
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 |
---|---|---|---|---|---|---|---|
06/17/2009 | 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 |
---|---|---|---|---|---|
11/28/2011 | SUPPL-2 | 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 |