Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209264
Company: AILEX PHARMS LLC

Products on ANDA 209264

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CROMOLYN SODIUM	CROMOLYN SODIUM	100MG/5ML	CONCENTRATE;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209264

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209264Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 209264

CROMOLYN SODIUM

CONCENTRATE;ORAL; 100MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CROMOLYN SODIUM	CROMOLYN SODIUM	100MG/5ML	CONCENTRATE;ORAL	Prescription	No	AA	209264	AILEX PHARMS LLC
CROMOLYN SODIUM	CROMOLYN SODIUM	100MG/5ML	CONCENTRATE;ORAL	Prescription	No	AA	202745	MICRO LABS LTD INDIA
CROMOLYN SODIUM	CROMOLYN SODIUM	100MG/5ML	CONCENTRATE;ORAL	Prescription	No	AA	202583	RISING
GASTROCROM	CROMOLYN SODIUM	100MG/5ML	CONCENTRATE;ORAL	Prescription	Yes	AA	020479	VIATRIS SPECIALTY