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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 020479

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NDA 020479 describes GASTROCROM, which is a drug marketed by Ucb Inc and Viatris Specialty and is included in two NDAs. It is available from two suppliers. Additional details are available on the GASTROCROM profile page.

The generic ingredient in GASTROCROM 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 020479

Tradename:	GASTROCROM
Applicant:	Viatris Specialty
Ingredient:	cromolyn sodium
Patents:	0

Pharmacology for NDA: 020479

Physiological Effect	Decreased Histamine Release

Medical Subject Heading (MeSH) Categories for 020479

Anti-Asthmatic Agents

Suppliers and Packaging for NDA: 020479

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479	NDA	Viatris Specialty LLC	0037-0678	0037-0678-96	12 POUCH in 1 CARTON (0037-0678-96) / 8 AMPULE in 1 POUCH (0037-0678-08) / 5 mL in 1 AMPULE
GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	51525-0470	51525-0470-9	12 POUCH in 1 CARTON (51525-0470-9) / 8 AMPULE in 1 POUCH (51525-0470-8) / 5 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CONCENTRATE;ORAL			Strength	100MG/5ML
Approval Date:	Feb 29, 1996	TE:	AA	RLD:	Yes

Expired US Patents for NDA 020479

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris Specialty	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479-001	Feb 29, 1996	4,421,762	⤷ Get Started Free
Viatris Specialty	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479-001	Feb 29, 1996	4,515,805	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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