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CROMOLYN SODIUM

ANDA

CROMOLYN SODIUM | A209264 | AILEX PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: GASTROCROM(TE code: AA)

Medicare Part B Spending

CMS physician-administered drug spending for Cromolyn Sodium (2023)

Total Spending

$341K

Total Claims

1,245

Beneficiaries

347

ASP Price

—

HCPCS: J7631 — Cromolyn sodium, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, per 10 milligrams

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain4 active DMFs6 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

CAMBREX PROFARMACO MILANO SRLCROMOLYN SODIUM / SODIUM CROMOGLICATE

DMF 81641989

OLON SPACROMOLYN SODIUM

DMF 82341989

FERMION OYCROMOLYN SODIUM

DMF 100061992

MICRO LABS LTDCROMOLYN SODIUM USP

DMF 375982022

AVENTIS PHARMA SAInactiveCROMOLYN SODIUM AND CROMOLYN SODIUM/LACTOSE BLEND

DMF 15811970

FRANCIS SPAInactiveCROMOLYN SODIUM

DMF 77191988

RALLIS INDIA LTDInactiveCROMOLYN SODIUM

DMF 82081989

SOCIETA ITALIANA MEDICINALI SCANDICCIInactiveCROMOLYN SODIUM

DMF 107361994

FARMHISPANIA SAInactiveCROMOLYN SODIUM

DMF 110501994

LIPHA SASInactiveCROMOLYN SODIUM

DMF 117241995

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 19, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/5ML

0 patents0 exclusivities▴

CONCENTRATE;ORAL | Approved: Oct 16, 2017

No patent or exclusivity listings for this strength.