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Details for New Drug Application (NDA): 204141

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NDA 204141 describes TOPICORT, which is a drug marketed by Taro and Taro Pharms North and is included in ten NDAs. It is available from three suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TOPICORT profile page.

The generic ingredient in TOPICORT is desoximetasone. There are seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the desoximetasone profile page.

Summary for NDA: 204141

Tradename:
TOPICORT
Applicant:
Taro
Ingredient:
desoximetasone
Patents:3
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)

Pharmacology for NDA: 204141

Suppliers and Packaging for NDA: 204141

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOPICORT
desoximetasone
SPRAY;TOPICAL 204141 NDA Taro Pharmaceuticals U.S.A., Inc. 51672-5281 51672-5281-0 1 BOTTLE in 1 CARTON (51672-5281-0) > 6 mL in 1 BOTTLE
TOPICORT
desoximetasone
SPRAY;TOPICAL 204141 NDA Taro Pharmaceuticals U.S.A., Inc. 51672-5281 51672-5281-3 1 BOTTLE in 1 CARTON (51672-5281-3) > 30 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;TOPICALStrength0.25%
Approval Date:Apr 11, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 11, 2016
Regulatory Exclusivity Use:NEW DOSAGE FORM
Patent:5,990,100Patent Expiration:Mar 24, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER
Patent:8,277,780Patent Expiration:Sep 1, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER


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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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