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Generated: August 22, 2018

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Details for New Drug Application (NDA): 050480

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NDA 050480 describes VIBRAMYCIN, which is a drug marketed by Pfizer and is included in four NDAs. It is available from two suppliers. Additional details are available on the VIBRAMYCIN profile page.

The generic ingredient in VIBRAMYCIN is doxycycline calcium. There are twenty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the doxycycline calcium profile page.
Summary for 050480
Tradename:VIBRAMYCIN
Applicant:Pfizer
Ingredient:doxycycline calcium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050480
Ingredient-typeTetracyclines
Suppliers and Packaging for NDA: 050480
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIBRAMYCIN doxycycline calcium SUSPENSION;ORAL 050480 NDA Pfizer Laboratories Div Pfizer Inc 0069-0971 N 0069-0971-93

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrengthEQ 50MG BASE/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
QuintilesIMS
Queensland Health
Cantor Fitzgerald
Chubb
McKesson
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Chinese Patent Office
Argus Health

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