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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202547
Company: ORBION PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET, ORALLY DISINTEGRATING;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
12/11/2017 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
02/01/2021 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

02/05/2020 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

02/05/2020 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

ARIPIPRAZOLE

TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202102 ALEMBIC PHARMS LTD
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202547 ORBION PHARMS
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 207240 SCIEGEN PHARMS INC
ARIPIPRAZOLE ARIPIPRAZOLE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090165 SQUARE PHARMS

TABLET, ORALLY DISINTEGRATING;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202102 ALEMBIC PHARMS LTD
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202547 ORBION PHARMS
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 207240 SCIEGEN PHARMS INC
ARIPIPRAZOLE ARIPIPRAZOLE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090165 SQUARE PHARMS
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