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Last Updated: July 8, 2020

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Promethazine hydrochloride - Generic Drug Details

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What are the generic sources for promethazine hydrochloride and what is the scope of freedom to operate?

Promethazine hydrochloride is the generic ingredient in thirteen branded drugs marketed by Wyeth Ayerst, Abbott, Akorn, Am Regent, Bedford Labs, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, West-ward Pharms Int, Wockhardt, Xgen Pharms, Altana, Mylan, Polymedica, Able, Cosette, Perrigo Israel, Taro, Watson Labs Inc, Usl Pharma, Alpharma Us Pharms, Actavis Mid Atlantic, Cenci, Amneal Pharms, Hi Tech Pharma, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Tris Pharma Inc, Vintage, Whiteworth Town Plsn, Ani Pharms, Wockhardt Bio Ag, Delcor Asset Corp, Amneal Pharms Ny, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, Lannett, Prinston Inc, Pvt Form, Quagen, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, and Bristol Myers Squibb, and is included in eighty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for promethazine hydrochloride. Fifty suppliers are listed for this compound.

Recent Clinical Trials for promethazine hydrochloride

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SponsorPhase
University of Alabama at BirminghamPhase 4
Hopital Psychiatrique De La CroixPhase 4
University of NottinghamPhase 4

See all promethazine hydrochloride clinical trials

Pharmacology for promethazine hydrochloride
Drug ClassPhenothiazine
Medical Subject Heading (MeSH) Categories for promethazine hydrochloride

US Patents and Regulatory Information for promethazine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Ayerst PHENERGAN promethazine hydrochloride INJECTABLE;INJECTION 008857-003 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Prinston Inc PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 040622-002 Jul 18, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Kvk Tech PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 040712-003 Jul 31, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
McKesson
Express Scripts
Boehringer Ingelheim
Baxter

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 verification 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.