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Details for New Drug Application (NDA): 020762

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NDA 020762 describes NASONEX, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from five suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the NASONEX profile page.

The generic ingredient in NASONEX 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: 020762

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

Pharmacology for NDA: 020762

Suppliers and Packaging for NDA: 020762

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NASONEX
mometasone furoate
SPRAY, METERED;NASAL 020762 NDA Merck Sharp & Dohme Corp. 0085-1288 0085-1288-01 1 BOTTLE, PUMP in 1 CARTON (0085-1288-01) > 120 SPRAY, METERED in 1 BOTTLE, PUMP
NASONEX
mometasone furoate
SPRAY, METERED;NASAL 020762 NDA Merck Sharp & Dohme Corp. 0085-1288 0085-1288-03 1 BOTTLE, PUMP in 1 CARTON (0085-1288-03) > 28 SPRAY, METERED in 1 BOTTLE, PUMP

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrengthEQ 0.05MG BASE/SPRAY
Approval Date:Oct 1, 1997TE:ABRLD:Yes
Patent:6,127,353*PEDPatent Expiration:Apr 3, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020762

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
NASONEX
mometasone furoate
SPRAY, METERED;NASAL020762-001Oct 1, 19974,472,393*PED► subscribe
Merck Sharp Dohme
NASONEX
mometasone furoate
SPRAY, METERED;NASAL020762-001Oct 1, 19976,723,713*PED► subscribe
Merck Sharp Dohme
NASONEX
mometasone furoate
SPRAY, METERED;NASAL020762-001Oct 1, 19975,837,699*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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