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Serving 500+ biopharmaceutical companies globally:

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Harvard Business School
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Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201695

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NDA 201695 describes FAMOTIDINE, which is a drug marketed by Perrigo, Sandoz, Mylan, Watson Labs, Hospira, Carlsbad, Apothecon, Fresenius Kabi Usa, Apotex, Ivax Sub Teva Pharms, Teva, Alembic Pharms Ltd, Dr Reddys Labs Ltd, Navinta Llc, Aurobindo Pharma Ltd, Wockhardt, Sun Pharm Inds, Lupin Ltd, Mylan Labs Ltd, Apotex Inc, Actavis Elizabeth, Athenex Inc, Perrigo R And D, Mylan Pharms Inc, Sun Pharm Inds Ltd, West-ward Pharms Int, Hi-tech Pharma Co, Novel Labs Inc, Eurohlth Intl Sarl, Abbvie, and Baxter Hlthcare, and is included in sixty-one NDAs. It is available from one hundred and eighteen 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 sixty-eight drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for NDA: 201695

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

Pharmacology for NDA: 201695

Suppliers and Packaging for NDA: 201695

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMOTIDINE
famotidine
SUSPENSION;ORAL 201695 ANDA Novel Laboratories, Inc. 40032-500 40032-500-11 50 mL in 1 BOTTLE (40032-500-11)
FAMOTIDINE
famotidine
SUSPENSION;ORAL 201695 ANDA GAVIS Pharmaceuticals, LLC 43386-500 43386-500-11 50 mL in 1 BOTTLE (43386-500-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength40MG/5ML
Approval Date:Dec 17, 2012TE:ABRLD:No


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Federal Trade Commission
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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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