Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 210479
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| 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 |
|---|---|---|---|---|---|---|---|
| 01/29/2019 | 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 INC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 210479 | AUROBINDO PHARMA LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 204171 | LANNETT CO INC |
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