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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
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Queensland Health
US Army
Covington
Teva
Merck
Dow
UBS
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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090440

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NDA 090440 describes FAMOTIDINE, which is a drug marketed by Hi-tech Pharma Co, Lupin Ltd, Navinta Llc, Apotex Inc, Apothecon, Athenex Inc, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, West-ward Pharms Int, Novel Labs Inc, Perrigo, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo Pharma Ltd, Carlsbad, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, Perrigo R And D, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Watson Labs, Wockhardt, Abbvie, and Baxter Hlthcare, and is included in sixty-one NDAs. It is available from one hundred and sixteen suppliers. Additional details are available on the FAMOTIDINE profile page.

The generic ingredient in FAMOTIDINE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and seventy-two drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.
Summary for 090440
Tradename:FAMOTIDINE
Applicant:Lupin Ltd
Ingredient:famotidine
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090440
Medical Subject Heading (MeSH) Categories for 090440
Suppliers and Packaging for NDA: 090440
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMOTIDINE famotidine FOR SUSPENSION;ORAL 090440 ANDA Lupin Pharmaceuticals, Inc 68180-150 68180-150-01 50 mL in 1 BOTTLE (68180-150-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength40MG/5ML
Approval Date:Jun 29, 2010TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
Dow
Chubb
Fuji
Covington
Colorcon
Citi
Accenture

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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