Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203906
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | ARIPIPRAZOLE | 1MG/ML | SOLUTION;ORAL | Prescription | AA | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/14/2015 | 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 |
---|---|---|---|---|---|
02/06/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
12/10/2019 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
02/23/2017 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
08/18/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
02/01/2017 | SUPPL-1 | Labeling-Package Insert |
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 |
ARIPIPRAZOLE | ARIPIPRAZOLE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 212870 | VISTAPHARM |
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