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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 202745

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NDA 202745 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 202745

Tradename:	CROMOLYN SODIUM
Applicant:	Micro Labs Ltd India
Ingredient:	cromolyn sodium
Patents:	0

Pharmacology for NDA: 202745

Physiological Effect	Decreased Histamine Release

Medical Subject Heading (MeSH) Categories for 202745

Anti-Asthmatic Agents

Suppliers and Packaging for NDA: 202745

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CROMOLYN SODIUM	cromolyn sodium	CONCENTRATE;ORAL	202745	ANDA	Micro Labs Limited	42571-132	42571-132-52	96 CARTON in 1 CARTON (42571-132-52) / 1 TRAY in 1 CARTON / 8 AMPULE in 1 TRAY / 5 mL in 1 AMPULE (42571-132-21)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CONCENTRATE;ORAL			Strength	100MG/5ML
Approval Date:	Apr 4, 2013	TE:	AA	RLD:	No

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