Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Daiichi Sankyo
UBS
Colorcon
Cantor Fitzgerald
Fuji
AstraZeneca
Farmers Insurance
Dow

Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020479

« Back to Dashboard

NDA 020479 describes GASTROCROM, which is a drug marketed by Ucb Inc and Mylan Speciality Lp and is included in two NDAs. It is available from three 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. Eighteen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.
Summary for 020479
Tradename:GASTROCROM
Applicant:Mylan Speciality Lp
Ingredient:cromolyn sodium
Patents:0
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020479
Physiological EffectDecreased Histamine Release
Medical Subject Heading (MeSH) Categories for 020479
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 MEDA Pharmaceuticals 0037-0678 N 0037-0678-96
GASTROCROM cromolyn sodium CONCENTRATE;ORAL 020479 NDA Jazz Pharmaceuticals Commercial Corp. 18860-678 E 18860-678-70

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength100MG/5ML
Approval Date:Feb 29, 1996TE:AARLD:Yes

Expired US Patents for NDA 020479

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp GASTROCROM cromolyn sodium CONCENTRATE;ORAL 020479-001 Feb 29, 1996 ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp GASTROCROM cromolyn sodium CONCENTRATE;ORAL 020479-001 Feb 29, 1996 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Chubb
Covington
QuintilesIMS
Moodys
Chinese Patent Office
Citi
Farmers Insurance
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.