Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216351
Company: RUBICON
Company: RUBICON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | ARIPIPRAZOLE | 1MG/ML | SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
10/27/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ARIPIPRAZOLE
SOLUTION;ORAL; 1MG/ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | ARIPIPRAZOLE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 203906 | AMNEAL PHARMS |
ARIPIPRAZOLE | ARIPIPRAZOLE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 204094 | APOTEX |
ARIPIPRAZOLE | ARIPIPRAZOLE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 210479 | AUROBINDO PHARMA LTD |
ARIPIPRAZOLE | ARIPIPRAZOLE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 215595 | CHARTWELL RX |
ARIPIPRAZOLE | ARIPIPRAZOLE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 216150 | HETERO LABS LTD III |
ARIPIPRAZOLE | ARIPIPRAZOLE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 204171 | LANNETT CO INC |
ARIPIPRAZOLE | ARIPIPRAZOLE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 216351 | RUBICON |
ARIPIPRAZOLE | ARIPIPRAZOLE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 212870 | VISTAPHARM |