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Last Updated: November 30, 2021

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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, Padagis Israel, Taro, Watson Labs Inc, Usl Pharma, Alpharma Us Pharms, Actavis Mid Atlantic, Cenci, Amneal Pharms, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, 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, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, and Bristol Myers Squibb, and is included in eighty-eight NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for promethazine hydrochloride
Recent Clinical Trials for promethazine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Beth Israel Deaconess Medical CenterPhase 4
University of FloridaPhase 4
University Hospital Inselspital, BernePhase 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
Marsam Pharms Llc PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride INJECTABLE;INJECTION 089477-001 May 2, 1988 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Cosette PROMETHEGAN promethazine hydrochloride SUPPOSITORY;RECTAL 087165-001 Aug 14, 1987 RX No Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Pharm Assoc PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SYRUP;ORAL 040643-001 Apr 26, 2006 AA RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Invatech PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 084233-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Wockhardt PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride INJECTABLE;INJECTION 040785-001 Sep 26, 2008 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lannett PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 080949-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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:

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McKesson
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Baxter

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