Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202745
Company: MICRO LABS LTD INDIA

Products on ANDA 202745

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 202745

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/04/2013	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
12/05/2023	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/14/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202745

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	MYLAN SPECIALITY LP