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Details for New Drug Application (NDA): 205641

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NDA 205641 describes ASMANEX HFA, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ASMANEX HFA profile page.

The generic ingredient in ASMANEX HFA is mometasone furoate. There are twenty-seven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

Summary for NDA: 205641

Tradename:
ASMANEX HFA
Applicant:
Merck Sharp Dohme
Ingredient:
mometasone furoate
Patents:1
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 205641

Suppliers and Packaging for NDA: 205641

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ASMANEX HFA
mometasone furoate
AEROSOL, METERED;INHALATION 205641 NDA Merck Sharp & Dohme Corp. 0085-4333 0085-4333-01 1 CANISTER in 1 CARTON (0085-4333-01) > 120 AEROSOL in 1 CANISTER
ASMANEX HFA
mometasone furoate
AEROSOL, METERED;INHALATION 205641 NDA Merck Sharp & Dohme Corp. 0085-4333 0085-4333-02 1 CANISTER in 1 CARTON (0085-4333-02) > 120 AEROSOL in 1 CANISTER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.10MG/INH
Approval Date:Apr 25, 2014TE:RLD:No
Patent:6,068,832Patent Expiration:Aug 27, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ASTHMA

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.20MG/INH
Approval Date:Apr 25, 2014TE:RLD:Yes
Patent:6,068,832Patent Expiration:Aug 27, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ASTHMA

Expired Orange Book Patents for NDA: 205641

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
ASMANEX HFA
mometasone furoate
AEROSOL, METERED;INHALATION205641-001Apr 25, 20145,889,015*PED► subscribe
Merck Sharp Dohme
ASMANEX HFA
mometasone furoate
AEROSOL, METERED;INHALATION205641-002Apr 25, 20146,057,307*PED► subscribe
Merck Sharp Dohme
ASMANEX HFA
mometasone furoate
AEROSOL, METERED;INHALATION205641-002Apr 25, 20145,889,015*PED► subscribe
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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. thinkBiotech performs no independent verifification 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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