Last Updated: August 3, 2026

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, 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 ten 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. Eleven 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

Medical Subject Heading (MeSH) Categories for 209453

Anti-Asthmatic Agents

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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