Details for New Drug Application (NDA): 060595

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NDA 060595 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 060595

Tradename:	TERRAMYCIN
Applicant:	Pfizer
Ingredient:	oxytetracycline calcium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	EQ 125MG BASE/5ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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