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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

Tradename:
BECONASE
Applicant:
Glaxosmithkline
Ingredient:
beclomethasone dipropionate
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

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

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