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Serving leading biopharmaceutical companies globally:

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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075282

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NDA 075282 describes CROMOLYN SODIUM, which is a drug marketed by Ailex Pharms Llc, Genera Pharms, Micro Labs Ltd India, Rising Pharms Inc, Akorn, Alcon, Apotex Inc, Actavis Mid Atlantic, Bausch And Lomb, Mylan Speciality Lp, Pharmascience Inc, Roxane, Teva Pharms, Watson Labs, Wockhardt, 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. Seventeen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.

Summary for 075282

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075282

Physiological EffectDecreased Histamine Release

Medical Subject Heading (MeSH) Categories for 075282

Suppliers and Packaging for NDA: 075282

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CROMOLYN SODIUM cromolyn sodium SOLUTION/DROPS;OPHTHALMIC 075282 ANDA Sandoz Inc 61314-237 61314-237-10 10 mL in 1 BOTTLE, PLASTIC (61314-237-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength4%
Approval Date:Jun 16, 1999TE:ATRLD:No


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Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Queensland Health
Merck
Mallinckrodt
Covington
QuintilesIMS
Johnson and Johnson
Citi
Argus Health

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