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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
US Department of Justice
QuintilesIMS
Cantor Fitzgerald
Federal Trade Commission
Cerilliant
Queensland Health
UBS
Fish and Richardson

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202583

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NDA 202583 describes CROMOLYN SODIUM, which is a drug marketed by Ailex Pharms Llc, Genera Pharms, Micro Labs Ltd India, Rising Pharms Inc, Akorn, Apotex Inc, Sandoz Inc, Actavis Mid Atlantic, Bausch And Lomb, Fera Pharms Llc, Mylan Speciality Lp, Roxane, Teva Pharms, Watson Labs, Wockhardt Bio Ag, Hh And P, and Perrigo, and is included in twenty-one NDAs. It is available from eleven suppliers. Additional details are available on the CROMOLYN SODIUM profile page.

The generic ingredient in CROMOLYN SODIUM is cromolyn sodium. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.
Summary for 202583
Tradename:CROMOLYN SODIUM
Applicant:Rising Pharms Inc
Ingredient:cromolyn sodium
Patents:0
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202583
Physiological EffectDecreased Histamine Release
Medical Subject Heading (MeSH) Categories for 202583
Suppliers and Packaging for NDA: 202583
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CROMOLYN SODIUM cromolyn sodium CONCENTRATE;ORAL 202583 ANDA Rising Pharmaceuticals, Inc. 16571-600 N 16571-600-96

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength100MG/5ML
Approval Date:Oct 27, 2011TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Healthtrust
Chinese Patent Office
Colorcon
US Department of Justice
Teva
Fuji
Chubb
Cipla

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