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Generated: November 18, 2018

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Details for New Drug Application (NDA): 021698

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NDA 021698 describes ZANTAC 150, which is a drug marketed by Glaxosmithkline, Glaxo Grp Ltd, and Sanofi Us, and is included in four NDAs. It is available from six suppliers. Additional details are available on the ZANTAC 150 profile page.

The generic ingredient in ZANTAC 150 is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. One hundred and forty-five suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
Summary for 021698
Tradename:ZANTAC 150
Applicant:Sanofi Us
Ingredient:ranitidine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021698
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZANTAC 150 ranitidine hydrochloride TABLET;ORAL 021698 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0120 0597-0120-06 1 BLISTER PACK in 1 CARTON (0597-0120-06) > 3 TABLET, COATED in 1 BLISTER PACK
ZANTAC 150 ranitidine hydrochloride TABLET;ORAL 021698 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0120 0597-0120-08 1 TABLET, COATED in 1 POUCH (0597-0120-08)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Aug 31, 2004TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Mar 13, 2007TE:RLD:Yes

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