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Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050808

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NDA 050808 describes SOLODYN, which is a drug marketed by Medicis and is included in one NDA. It is available from three suppliers. There are nine patents protecting this drug and four Paragraph IV challenges. Additional details are available on the SOLODYN profile page.

The generic ingredient in SOLODYN is minocycline hydrochloride. There are thirteen drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.

Summary for 050808

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:9
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 050808

Ingredient-typeTetracyclines

Medical Subject Heading (MeSH) Categories for 050808

Suppliers and Packaging for NDA: 050808

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLODYN
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL 050808 NDA AUTHORIZED GENERIC Impax Generics 0115-9935 0115-9935-08 1 BOTTLE in 1 CARTON (0115-9935-08) > 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
SOLODYN
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL 050808 NDA AUTHORIZED GENERIC Impax Generics 0115-9936 0115-9936-08 1 BOTTLE in 1 CARTON (0115-9936-08) > 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 8, 2006TE:RLD:Yes
Patent:► SubscribePatent Expiration:Feb 19, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
Patent:► SubscribePatent Expiration:Jun 24, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:► SubscribePatent Expiration:Mar 7, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE


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Serving leading biopharmaceutical companies globally:

Chubb
US Army
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Cerilliant

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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