Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212494
Company: TULEX PHARMS INC

Products on ANDA 212494

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212494

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/11/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212494

AMINOCAPROIC ACID

SOLUTION;ORAL; 0.25GM/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	212780	AMNEAL
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	216464	ANNORA PHARMA
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	216804	AUROBINDO PHARMA
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	213825	BELCHER
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	214140	CARNEGIE
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	215510	FLORIDA
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	213213	SUNNY
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	214458	TARO
AMINOCAPROIC ACID	AMINOCAPROIC ACID	0.25GM/ML	SOLUTION;ORAL	Prescription	No	AA	212494	TULEX PHARMS INC