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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 213811


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NDA 213811 describes BECLOMETHASONE DIPROPIONATE, which is a drug marketed by Amneal Ireland Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the BECLOMETHASONE DIPROPIONATE profile page.

The generic ingredient in BECLOMETHASONE DIPROPIONATE is beclomethasone dipropionate. 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 profile page.
Summary for 213811
Tradename:BECLOMETHASONE DIPROPIONATE
Applicant:Amneal Ireland Ltd
Ingredient:beclomethasone dipropionate
Patents:0
Pharmacology for NDA: 213811
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Suppliers and Packaging for NDA: 213811
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BECLOMETHASONE DIPROPIONATE beclomethasone dipropionate AEROSOL, METERED;INHALATION 213811 ANDA Amneal Pharmaceuticals NY LLC 69238-1289 69238-1289-4 1 CANISTER in 1 CARTON (69238-1289-4) / 120 AEROSOL, METERED in 1 CANISTER
BECLOMETHASONE DIPROPIONATE beclomethasone dipropionate AEROSOL, METERED;INHALATION 213811 ANDA Amneal Pharmaceuticals NY LLC 69238-1290 69238-1290-4 1 CANISTER in 1 CARTON (69238-1290-4) / 120 AEROSOL, METERED in 1 CANISTER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.04MG/INH
Approval Date:Dec 16, 2025TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.08MG/INH
Approval Date:Dec 16, 2025TE:RLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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