Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075437
Company: VIRTUS

Products on ANDA 075437

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075437

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/21/2000	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
08/10/2022	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 075437

CROMOLYN SODIUM

SOLUTION;INHALATION; 10MG/ML
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION;INHALATION	Prescription	No	AN	209453	AILEX PHARMS LLC
CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION;INHALATION	Prescription	No	AN	213658	MICRO LABS
CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION;INHALATION	Prescription	No	AN	075271	TEVA PHARMS
CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION;INHALATION	Prescription	No	AN	075437	VIRTUS
CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION;INHALATION	Prescription	No	AN	075346	WOCKHARDT BIO AG