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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202547
Company: ORBION PHARMS

Products on ANDA 202547

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202547

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-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 202547

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
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
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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