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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 090954

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NDA 090954 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 090954

Tradename:	CROMOLYN SODIUM
Applicant:	Genera Pharms
Ingredient:	cromolyn sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 090954

Anti-Asthmatic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CONCENTRATE;ORAL			Strength	100MG/5ML
Approval Date:	Dec 18, 2009	TE:		RLD:	No

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