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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 two 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. Forty-six suppliers are listed for this compound. There are fifteen tentative approvals for this compound. Additional details are available on the minocycline hydrochloride profile page.

Summary for NDA: 050808

Tradename:
SOLODYN
Applicant:
Medicis
Ingredient:
minocycline hydrochloride
Patents:9
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 050808

Ingredient-typeTetracyclines

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 Physicians Total Care, Inc. 54868-6285 54868-6285-0 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-6285-0)
SOLODYN
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL 050808 NDA Valeant Pharmaceuticals North America LLC 99207-463 99207-463-01 20 BLISTER PACK in 1 CARTON (99207-463-01) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 45MG BASE
Approval Date:May 8, 2006TE:RLD:No
Patent:7,790,705Patent Expiration:Jun 24, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:7,919,483Patent Expiration:Mar 7, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:8,252,776Patent Expiration:Jun 24, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE


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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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