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Serving leading biopharmaceutical companies globally:

Express Scripts
Cerilliant
Johnson and Johnson
McKesson
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QuintilesIMS
Chubb
Julphar
Mallinckrodt

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075786

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NDA 075786 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 seventeen 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 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 075786

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075786

Suppliers and Packaging for NDA: 075786

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMOTIDINE famotidine TABLET;ORAL 075786 ANDA STAT Rx USA LLC 16590-281 16590-281-20 20 TABLET, FILM COATED in 1 BOTTLE (16590-281-20)
FAMOTIDINE famotidine TABLET;ORAL 075786 ANDA STAT Rx USA LLC 16590-281 16590-281-60 60 TABLET, FILM COATED in 1 BOTTLE (16590-281-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Apr 16, 2001TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Apr 16, 2001TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Baxter
Fuji
US Department of Justice
Healthtrust
Mallinckrodt
Federal Trade Commission
Cerilliant
Fish and Richardson
US Army
UBS

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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