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Details for New Drug Application (NDA): 018584

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NDA 018584 describes BECONASE, which is a drug marketed by Glaxosmithkline and is included in two NDAs. Additional details are available on the BECONASE profile page.

The generic ingredient in BECONASE is beclomethasone dipropionate monohydrate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the beclomethasone dipropionate monohydrate profile page.

Summary for NDA: 018584

beclomethasone dipropionate
Therapeutic Class:Respiratory Tract Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:AEROSOL, METERED;NASALStrength0.042MG/INH
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired Orange Book Patents for NDA: 018584

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
beclomethasone dipropionate
AEROSOL, METERED;NASAL018584-001Approved Prior to Jan 1, 19824,364,923► subscribe
beclomethasone dipropionate
AEROSOL, METERED;NASAL018584-001Approved Prior to Jan 1, 19824,414,209► subscribe
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