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Serving leading biopharmaceutical companies globally:

Harvard Business School
Federal Trade Commission
Queensland Health

Generated: November 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090623

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NDA 090623 describes RANITIDINE HYDROCHLORIDE, which is a drug marketed by Ranbaxy, Wockhardt, Apotex Inc, Bio Pharm Inc, Pharm Assoc, Dr Reddys Labs Inc, Amneal Pharms, Strides Pharma, Watson Labs, Sandoz, Aurobindo Pharma Ltd, Mylan, Actavis Mid Atlantic, Amneal Pharms Ny, Watson Labs Inc, Perrigo R And D, Sun Pharm Inds Ltd, Zydus Pharms Usa Inc, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Tolmar, Teva, West-ward Pharms Int, Boehringer Ingelheim, Bedford, Ivax Sub Teva Pharms, Mylan Labs Ltd, Taro, Hi Tech Pharma, Apotex, Par Pharm, Breckenridge Pharm, Silarx, Vintage Pharms, Nostrum Labs Inc, Contract Pharmacal, and Perrigo, and is included in sixty-one NDAs. It is available from one hundred and thirty-five suppliers. Additional details are available on the RANITIDINE HYDROCHLORIDE profile page.

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

Summary for 090623

Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090623

Suppliers and Packaging for NDA: 090623

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ranitidine hydrochloride
SYRUP;ORAL 090623 ANDA Aurobindo Pharma Limited 65862-431 65862-431-74 474 mL in 1 BOTTLE (65862-431-74)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrengthEQ 15MG BASE/ML
Approval Date:Jul 28, 2010TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Johnson and Johnson
US Department of Justice
Fish and Richardson
Daiichi Sankyo
Cantor Fitzgerald
US Army

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