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Generated: January 16, 2019

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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 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 fourteen drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 050444
Tradename:MINOCIN
Applicant:Rempex Pharms
Ingredient:minocycline hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 050444
Medical Subject Heading (MeSH) Categories for 050444
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)

Profile 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:➤ Sign UpPatent Expiration:May 12, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING BACTERIAL INFECTIONS
Patent:➤ Sign UpPatent Expiration:May 12, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING BACTERIAL INFECTIONS

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