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Covington
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US Department of Justice
Merck
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Colorcon

Generated: July 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050649

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NDA 050649 describes MINOCIN, which is a drug marketed by Precision Dermat, Triax Pharms, Lederle, and Rempex Pharms, and is included in five NDAs. It is available from five suppliers. There are two patents protecting this drug. Additional details are available on the MINOCIN profile page.

The generic ingredient in MINOCIN 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 050649
Tradename:MINOCIN
Applicant:Precision Dermat
Ingredient:minocycline hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 050649
Ingredient-typeTetracyclines
Medical Subject Heading (MeSH) Categories for 050649
Suppliers and Packaging for NDA: 050649
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOCIN minocycline hydrochloride CAPSULE;ORAL 050649 NDA Onset Dermatologics LLC 16781-400 N 16781-400-05
MINOCIN minocycline hydrochloride CAPSULE;ORAL 050649 NDA Onset Dermatologics LLC 16781-400 N 16781-400-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:May 31, 1990TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:May 31, 1990TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 12, 2001TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
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Healthtrust
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Dow
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