Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216150
Company: HETERO LABS LTD III

Products on ANDA 216150

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARIPIPRAZOLE	ARIPIPRAZOLE	1MG/ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216150

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/01/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216150

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
ARIPIPRAZOLE	ARIPIPRAZOLE	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	210479	AUROBINDO PHARMA LTD
ARIPIPRAZOLE	ARIPIPRAZOLE	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	215595	CHARTWELL RX
ARIPIPRAZOLE	ARIPIPRAZOLE	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	216150	HETERO LABS LTD III
ARIPIPRAZOLE	ARIPIPRAZOLE	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	204171	LANNETT CO INC
ARIPIPRAZOLE	ARIPIPRAZOLE	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	216351	RUBICON
ARIPIPRAZOLE	ARIPIPRAZOLE	1MG/ML	SOLUTION;ORAL	Prescription	No	AA	212870	VISTAPHARM