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Generated: November 16, 2018

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Details for New Drug Application (NDA): 060586

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NDA 060586 describes TERRAMYCIN, which is a drug marketed by Pfizer and Casper Pharma Llc and is included in eight NDAs. Additional details are available on the TERRAMYCIN profile page.

The generic ingredient in TERRAMYCIN is oxytetracycline hydrochloride; polymyxin b sulfate. There are thirty-six drug master file entries for this compound. Additional details are available on the oxytetracycline hydrochloride; polymyxin b sulfate profile page.
Summary for 060586
Tradename:TERRAMYCIN
Applicant:Pfizer
Ingredient:oxytetracycline hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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