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Details for New Drug Application (NDA): 050444

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NDA 050444 describes MINOCIN, which is a drug marketed by Triax Pharms, Lederle, Rempex Pharms Inc, and Precision Dermat, and is included in five NDAs. It is available from four 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. 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: 050444

Tradename:
MINOCIN
Applicant:
Rempex Pharms Inc
Ingredient:
minocycline hydrochloride
Patents:2
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 050444

Ingredient-typeTetracyclines

Suppliers and Packaging for NDA: 050444

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MINOCIN
minocycline hydrochloride
INJECTABLE;INJECTION 050444 NDA Rempex Pharmaceuticals, Inc 54531-100 54531-100-01 10 INJECTION in 1 CARTON (54531-100-01)
MINOCIN
minocycline hydrochloride
INJECTABLE;INJECTION 050444 NDA The Medicines Company 65293-014 65293-014-10 10 VIAL in 1 CARTON (65293-014-10) > 1 INJECTION in 1 VIAL (65293-014-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes
Patent:9,084,802Patent Expiration:May 12, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING BACTERIAL INFECTIONS
Patent:9,278,105Patent Expiration:May 12, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING BACTERIAL INFECTIONS


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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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