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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Boehringer Ingelheim
Medtronic
Express Scripts
Moodys
US Department of Justice
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Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091288

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NDA 091288 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-six 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-three suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for NDA: 091288

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

Pharmacology for NDA: 091288

Suppliers and Packaging for NDA: 091288

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride
SYRUP;ORAL 091288 ANDA Silarx Pharmaceuticals, Inc. 54838-550 54838-550-80 473 mL in 1 BOTTLE, PLASTIC (54838-550-80)
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride
SYRUP;ORAL 091288 ANDA American Health Packaging 60687-260 60687-260-69 5 TRAY in 1 CASE (60687-260-69) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-260-48) > 10 mL in 1 CUP, UNIT-DOSE (60687-260-42)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrengthEQ 15MG BASE/ML
Approval Date:Dec 9, 2010TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

UBS
Deloitte
McKinsey
Covington
Teva
Daiichi Sankyo
Chinese Patent Office
Johnson and Johnson
US Department of Justice
Cantor Fitzgerald

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