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Details for New Drug Application (NDA): 021812

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NDA 021812 describes WOMEN'S ROGAINE, which is a drug marketed by Johnson And Johnson 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 WOMEN'S ROGAINE profile page.

The generic ingredient in WOMEN'S ROGAINE is minoxidil. There are eight drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the minoxidil profile page.

Summary for NDA: 021812

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021812

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEN'S ROGAINE
minoxidil
AEROSOL, FOAM;TOPICAL 021812 NDA Johnson & Johnson Consumer Inc. 42002-107 42002-107-11 1 CAN in 1 CARTON (42002-107-11) > 60 g in 1 CAN
MEN'S ROGAINE
minoxidil
AEROSOL, FOAM;TOPICAL 021812 NDA Johnson & Johnson Consumer Inc. 42002-107 42002-107-12 2 CAN in 1 CARTON (42002-107-12) > 60 g in 1 CAN

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:AEROSOL, FOAM;TOPICALStrength5%
Approval Date:Jan 20, 2006TE:RLD:Yes
Patent:6,946,120Patent Expiration:Apr 20, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL AEROSOL HAIR REGROWTH TREATMENT

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:AEROSOL, FOAM;TOPICALStrength5%
Approval Date:Feb 28, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 28, 2017
Regulatory Exclusivity Use:NEW PRODUCT
Patent:6,946,120Patent Expiration:Apr 20, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL AEROSOL HAIR REGROWTH TREATMENT


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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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