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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Express Scripts
Healthtrust
Federal Trade Commission
Fish and Richardson
Novartis
Daiichi Sankyo
Chinese Patent Office
Johnson and Johnson
Harvard Business School

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040712

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NDA 040712 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, 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. Six suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 040712
Tradename:PROMETHAZINE HYDROCHLORIDE
Applicant:Kvk Tech
Ingredient:promethazine hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040712
Ingredient-typePhenothiazines
Medical Subject Heading (MeSH) Categories for 040712
Suppliers and Packaging for NDA: 040712
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 040712 ANDA Liberty Pharmaceuticals, Inc. 0440-8195 0440-8195-12 12 TABLET in 1 BOTTLE, PLASTIC (0440-8195-12)
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 040712 ANDA Major Pharmaceuticals 0904-5840 0904-5840-61 100 TABLET in 1 BOX, UNIT-DOSE (0904-5840-61)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jul 31, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:May 4, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jul 31, 2006TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
UBS
Dow
Boehringer Ingelheim
Fish and Richardson
Colorcon
Federal Trade Commission
Johnson and Johnson
Deloitte

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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