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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216208
Company: AUROBINDO PHARMA

Products on ANDA 216208

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 216208

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/18/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216208

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	216208	AUROBINDO PHARMA
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
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	216208	AUROBINDO PHARMA
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
ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	090165	SQUARE PHARMS

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