Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214068
Company: TEVA PHARMS USA INC
Company: TEVA PHARMS USA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RISPERIDONE | RISPERIDONE | 12.5MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AB | No | No |
| RISPERIDONE | RISPERIDONE | 25MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AB | No | No |
| RISPERIDONE | RISPERIDONE | 37.5MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | AB | No | No |
| RISPERIDONE | RISPERIDONE | 50MG/VIAL | INJECTABLE;INTRAMUSCULAR | 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 |
|---|---|---|---|---|---|---|---|
| 12/05/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
RISPERIDONE
INJECTABLE;INTRAMUSCULAR; 12.5MG/VIAL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL CONSTA | RISPERIDONE | 12.5MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | Yes | AB | 021346 | JANSSEN PHARMS |
| RISPERIDONE | RISPERIDONE | 12.5MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | No | AB | 214068 | TEVA PHARMS USA INC |
INJECTABLE;INTRAMUSCULAR; 25MG/VIAL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL CONSTA | RISPERIDONE | 25MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | Yes | AB | 021346 | JANSSEN PHARMS |
| RISPERIDONE | RISPERIDONE | 25MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | No | AB | 214068 | TEVA PHARMS USA INC |
INJECTABLE;INTRAMUSCULAR; 37.5MG/VIAL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL CONSTA | RISPERIDONE | 37.5MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | Yes | AB | 021346 | JANSSEN PHARMS |
| RISPERIDONE | RISPERIDONE | 37.5MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | No | AB | 214068 | TEVA PHARMS USA INC |
INJECTABLE;INTRAMUSCULAR; 50MG/VIAL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL CONSTA | RISPERIDONE | 50MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | Yes | AB | 021346 | JANSSEN PHARMS |
| RISPERIDONE | RISPERIDONE | 50MG/VIAL | INJECTABLE;INTRAMUSCULAR | Prescription | No | AB | 214068 | TEVA PHARMS USA INC |