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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Harvard Business School

Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089013

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NDA 089013 describes PROMETHAZINE, which is a drug marketed by Cenci, Vintage, Abbott, Akorn, Bedford Labs, Hospira, Luitpold, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, West-ward Pharms Int, Wockhardt, X-gen Pharms, Able, G And W Labs, Perrigo New York, Taro, Watson Labs Inc, Amneal Pharms, Hi Tech Pharma, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Tris Pharma Inc, Whiteworth Town Plsn, Amneal Pharms Ny, Heritage Pharma, Impax Labs, Ivax Sub Teva Pharms, Kvk Tech, Lannett, Mylan, Prinston Inc, Pvt Form, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Wockhardt Bio Ag, Ani Pharms, and Hi-tech Pharma Co, and is included in ninety-seven NDAs. Additional details are available on the PROMETHAZINE profile page.

The generic ingredient in PROMETHAZINE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 089013
Ingredient:promethazine hydrochloride
Therapeutic Class:Antiemetics
Respiratory Tract Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 089013

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrength6.25MG/5ML
Approval Date:Sep 20, 1985TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Daiichi Sankyo
US Department of Justice
Farmers Insurance

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