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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078890

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NDA 078890 describes RANITIDINE HYDROCHLORIDE, which is a drug marketed by Dr Reddys Labs Ltd, Mylan, Sandoz, Teva, Bedford, Mylan Labs Ltd, West-ward Pharms Int, Zydus Pharms Usa Inc, Actavis Mid Atlantic, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Bio Pharm Inc, Breckenridge Pharm, Hi Tech Pharma, Nostrum Labs Inc, Pharm Assoc, Ranbaxy, Silarx, Taro, Tolmar, Vintage Pharms, Wockhardt, Amneal Pharms Ny, Apotex, Boehringer Ingelheim, Contract Pharmacal, Dr Reddys Labs Inc, Glenmark Pharms Inc, Ivax Sub Teva Pharms, Par Pharm, Perrigo, Perrigo R And D, Strides Pharma, Sun Pharm Inds Ltd, Watson Labs, and Watson Labs Inc, and is included in sixty-three NDAs. It is available from one hundred and thirty-three 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 suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for 078890

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

Pharmacology for NDA: 078890

Suppliers and Packaging for NDA: 078890

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANITIDINE HYDROCHLORIDE ranitidine hydrochloride SYRUP;ORAL 078890 ANDA Par Pharmaceutical 0603-9418 0603-9418-58 473 mL in 1 BOTTLE (0603-9418-58)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrengthEQ 15MG BASE/ML
Approval Date:Jul 1, 2010TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Fish and Richardson
Healthtrust
Deloitte
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Julphar
Argus Health
Baxter
AstraZeneca
QuintilesIMS

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