Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213658
Company: MICRO LABS

Products on ANDA 213658

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 213658

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213658

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