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Serving 500+ biopharmaceutical companies globally:

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Generated: June 27, 2017

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 Actavis Mid Atlantic, Bausch And Lomb, Akorn, Mylan Speciality Lp, Apotex Inc, Perrigo, Pharmascience Inc, Micro Labs Ltd India, Wockhardt, Genera Pharms, Watson Labs, Teva Pharms, Roxane, Hh And P, Alcon, and Pack Pharms Llc, and is included in nineteen NDAs. It is available from ten 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. Sixteen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.

Summary for NDA: 202583

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

Pharmacology for NDA: 202583

Physiological EffectDecreased Histamine Release

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 Pack Pharmaceuticals, LLC 16571-600 16571-600-96 12 POUCH in 1 CARTON (16571-600-96) > 8 AMPULE in 1 POUCH > 5 mL in 1 AMPULE

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Baxter
Johnson and Johnson
Chubb
Argus Health
Queensland Health
AstraZeneca
Boehringer Ingelheim
Express Scripts
Cerilliant
US Army

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