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NDA

CROMOLYN SODIUM | N018596 | KING PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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
Mar 2, 2004	SUPPL -30	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INHALATION | Approved: May 28, 1982

No patent or exclusivity listings for this strength.