Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203906
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
02/23/2017 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 204171 SILARX PHARMS INC

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