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Serving leading biopharmaceutical companies globally:

Queensland Health
Johnson and Johnson
Harvard Business School
Chinese Patent Office

Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074443

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NDA 074443 describes CROLOM, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from three suppliers. Additional details are available on the CROLOM profile page.

The generic ingredient in CROLOM 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: 074443

Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 074443

Physiological EffectDecreased Histamine Release

Suppliers and Packaging for NDA: 074443

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cromolyn sodium
SOLUTION/DROPS;OPHTHALMIC 074443 ANDA Bausch & Lomb Incorporated 24208-961 24208-961-10 1 BOTTLE, DROPPER in 1 CARTON (24208-961-10) > 10 mL in 1 BOTTLE, DROPPER
cromolyn sodium
SOLUTION/DROPS;OPHTHALMIC 074443 ANDA Proficient Rx LP 63187-473 63187-473-10 1 BOTTLE, DROPPER in 1 CARTON (63187-473-10) > 10 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength4%
Approval Date:Jan 30, 1995TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Farmers Insurance
Fish and Richardson
Federal Trade Commission
Harvard Business School
US Army

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