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Last Updated: December 30, 2025

Details for New Drug Application (NDA): 209453

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NDA 209453 describes CROMOLYN SODIUM, which is a drug marketed by Ailex Pharms Llc, Genera Pharms, Micro Labs Ltd India, Rising, Apotex Inc, Sandoz, Sciegen Pharms Inc, Actavis Mid Atlantic, Bausch, Eugia Pharma, Fera Pharms Llc, Hikma, Micro Labs, Roxane, Teva Pharms, Watson Labs, Wockhardt Bio Ag, Bausch And Lomb, Hh And P, and Perrigo, and is included in twenty-two NDAs. It is available from twelve suppliers. Additional details are available on the CROMOLYN SODIUM profile page.

The generic ingredient in CROMOLYN SODIUM is cromolyn sodium. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.

Summary for 209453

Tradename:	CROMOLYN SODIUM
Applicant:	Ailex Pharms Llc
Ingredient:	cromolyn sodium
Patents:	0

Pharmacology for NDA: 209453

Physiological Effect	Decreased Histamine Release

Medical Subject Heading (MeSH) Categories for 209453

Anti-Asthmatic Agents

Suppliers and Packaging for NDA: 209453

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CROMOLYN SODIUM	cromolyn sodium	SOLUTION;INHALATION	209453	ANDA	Ritedose Pharmaceuticals, LLC	76204-028	76204-028-60	2 POUCH in 1 CARTON (76204-028-60) / 30 AMPULE in 1 POUCH (76204-028-12) / 2 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	10MG/ML
Approval Date:	Oct 16, 2017	TE:	AN	RLD:	No

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