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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Chinese Patent Office
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Merck
Accenture
UBS
US Army
Cipla

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040500

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NDA 040500 describes PROMETHAZINE HYDROCHLORIDE, which is a drug marketed by 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, Vintage, 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 eighty-seven NDAs. It is available from sixty-eight suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE profile page.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 040500
Tradename:PROMETHAZINE HYDROCHLORIDE
Applicant:Perrigo New York
Ingredient:promethazine hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040500
Ingredient-typePhenothiazines
Medical Subject Heading (MeSH) Categories for 040500
Suppliers and Packaging for NDA: 040500
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SUPPOSITORY;RECTAL 040500 ANDA Rebel Distributors Corp 21695-649 E 21695-649-12
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SUPPOSITORY;RECTAL 040500 ANDA PD-Rx Pharmaceuticals, Inc. 43063-060 N 43063-060-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength12.5MG
Approval Date:Jun 30, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength25MG
Approval Date:Jun 30, 2003TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
McKinsey
Fish and Richardson
Deloitte
Citi
Mallinckrodt
Harvard Business School
Healthtrust
Accenture

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