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INTAL

NDA

CROMOLYN SODIUM | N016990 | SANOFI AVENTIS US 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Arnall Golden Gregory LLP - Citizen Petition FDA-2013-P-0665 · 4 docket documents Arnall Golden Gregory LLP filed this petition on behalf of an unnamed petitioner requesting that the FDA determine that Intal (cromolyn sodium) Inhalation Capsule, 20 mg (NDA 016990), which was voluntarily withdrawn from the market by Sanofi Aventis, was withdrawn for reasons other than safety or ef	505(q)	2013-06-14	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

10 trials from ClinicalTrials.gov, 7 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema NCT01933464	Phase 1/2	Completed	University of California, San Diego	10	2013-08 → 2014-04
Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease NCT02547818	Phase 3	Completed	AZTherapies, Inc.	620	2015-09-15 → 2020-11-18
Mast Cells in Male Pelvic Pain and and Lower Urinary Tract Dysfunction NCT03167216	Early Phase 1	Completed	Northwestern University	20	2017-08-01 → 2022-06-30
Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis NCT02371941	Phase 4	Completed	University of Tennessee	16	2014-12 → 2017-12
Phase 1 Study of ALZT-OP1 Combination Therapy in Normal Healthy Volunteers NCT02482324	Phase 1	Completed	AZTherapies, Inc.	26	2015-06 → 2015-07
Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus NCT00745199	Phase 2	Completed	Shiraz University of Medical Sciences	62	2008-05 → 2009-06
Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042)NCT02566252	Phase 1	Completed	Pulmotect, Inc.	16	2015-07 → 2016-03
Cromolyn Detection of Silent Aspiration NCT01841307	Phase 1	Terminated	University of California, San Francisco	16	2015-07 → 2017-09
Treatment of Acute Stroke With Cromolyn(Single Dose)NCT01175525	Phase 3	UNKNOWN	Wolfson Medical Center	—	—
Safety and Efficacy of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)NCT03202147	Phase 2	Withdrawn	AZTherapies, Inc.	—	2023-12 → 2024-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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.

Products (1)

#001 — 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;INHALATION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.