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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 Glaxo Grp Ltd, Glaxosmithkline, and Boehringer Ingelheim, and is included in four NDAs. It is available from five suppliers. Additional details are available on the ZANTAC 150 profile page.

The generic ingredient in ZANTAC 150 is ranitidine hydrochloride. There are forty-two drug master file entries for this compound. One hundred and thirty-seven suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for NDA: 021698

Tradename:
ZANTAC 150
Applicant:
Boehringer Ingelheim
Ingredient:
ranitidine hydrochloride
Patents:0
Therapeutic Class:Gastrointestinal Agents
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)

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Mar 13, 2007TE:RLD:No

Expired Orange Book Patents for NDA: 021698

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
ZANTAC 150
ranitidine hydrochloride
TABLET;ORAL021698-002Mar 13, 20075,098,715► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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