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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office
Farmers Insurance

Generated: December 15, 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. Seventeen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.

Summary for 074443

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

Pharmacology for NDA: 074443

Physiological EffectDecreased Histamine Release

Medical Subject Heading (MeSH) Categories for 074443

Suppliers and Packaging for NDA: 074443

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CROLOM 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
CROLOM 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:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrength4%
Approval Date:Jan 30, 1995TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School
Queensland Health

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