Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213669
Company: HETERO LABS LTD V
Company: HETERO LABS LTD V
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BREXPIPRAZOLE | BREXPIPRAZOLE | 0.25MG | TABLET;ORAL | Prescription | AB | No | No |
BREXPIPRAZOLE | BREXPIPRAZOLE | 0.5MG | TABLET;ORAL | Prescription | AB | No | No |
BREXPIPRAZOLE | BREXPIPRAZOLE | 1MG | TABLET;ORAL | Prescription | AB | No | No |
BREXPIPRAZOLE | BREXPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | AB | No | No |
BREXPIPRAZOLE | BREXPIPRAZOLE | 3MG | TABLET;ORAL | Prescription | AB | No | No |
BREXPIPRAZOLE | BREXPIPRAZOLE | 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 |
---|---|---|---|---|---|---|---|
11/20/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
BREXPIPRAZOLE
TABLET;ORAL; 0.25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BREXPIPRAZOLE | BREXPIPRAZOLE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 213782 | ALKEM LABS LTD |
BREXPIPRAZOLE | BREXPIPRAZOLE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 213669 | HETERO LABS LTD V |
BREXPIPRAZOLE | BREXPIPRAZOLE | 0.25MG | TABLET;ORAL | Prescription | No | AB | 213758 | OPTIMUS |
REXULTI | BREXPIPRAZOLE | 0.25MG | TABLET;ORAL | Prescription | Yes | AB | 205422 | OTSUKA |
TABLET;ORAL; 0.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BREXPIPRAZOLE | BREXPIPRAZOLE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 213669 | HETERO LABS LTD V |
BREXPIPRAZOLE | BREXPIPRAZOLE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 213758 | OPTIMUS |
REXULTI | BREXPIPRAZOLE | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 205422 | OTSUKA |
TABLET;ORAL; 1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BREXPIPRAZOLE | BREXPIPRAZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 213669 | HETERO LABS LTD V |
BREXPIPRAZOLE | BREXPIPRAZOLE | 1MG | TABLET;ORAL | Prescription | No | AB | 213758 | OPTIMUS |
REXULTI | BREXPIPRAZOLE | 1MG | TABLET;ORAL | Prescription | Yes | AB | 205422 | OTSUKA |
TABLET;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BREXPIPRAZOLE | BREXPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 213669 | HETERO LABS LTD V |
BREXPIPRAZOLE | BREXPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 213758 | OPTIMUS |
REXULTI | BREXPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | Yes | AB | 205422 | OTSUKA |
TABLET;ORAL; 3MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BREXPIPRAZOLE | BREXPIPRAZOLE | 3MG | TABLET;ORAL | Prescription | No | AB | 213669 | HETERO LABS LTD V |
BREXPIPRAZOLE | BREXPIPRAZOLE | 3MG | TABLET;ORAL | Prescription | No | AB | 213758 | OPTIMUS |
REXULTI | BREXPIPRAZOLE | 3MG | TABLET;ORAL | Prescription | Yes | AB | 205422 | OTSUKA |
TABLET;ORAL; 4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BREXPIPRAZOLE | BREXPIPRAZOLE | 4MG | TABLET;ORAL | Prescription | No | AB | 213669 | HETERO LABS LTD V |
BREXPIPRAZOLE | BREXPIPRAZOLE | 4MG | TABLET;ORAL | Prescription | No | AB | 213758 | OPTIMUS |
REXULTI | BREXPIPRAZOLE | 4MG | TABLET;ORAL | Prescription | Yes | AB | 205422 | OTSUKA |