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Generated: May 24, 2017

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Promethazine hydrochloride - Generic Drug Details

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What are the generic drug sources for promethazine hydrochloride and what is the scope of promethazine hydrochloride patent protection?

Promethazine hydrochloride
is the generic ingredient in thirteen branded drugs marketed by Perrigo New York, Polymedica, Watson Labs, Taro, Ivax Sub Teva Pharms, Able, Teva, West-ward Pharms Int, Kvk Tech, Cenci, Impax Labs, Pvt Form, Luitpold, Pharm Assoc, Abbott, Prinston Inc, Bedford Labs, Mylan Pharms Inc, Hi Tech Pharma, Tablicaps, G And W Labs, Sandoz, Delcor Asset Corp, X-gen Pharms, Hospira, Vintage, Lannett, Actavis Mid Atlantic, Wockhardt, Teva Pharms Usa, Mylan, Sun Pharm Inds, Akorn, Wyeth Ayerst, Marsam Pharms Llc, Sun Pharm Inds Inc, Mylan Institutional, Alpharma Us Pharms, Heritage Pharma, Tris Pharma Inc, Bristol Myers Squibb, Watson Labs Inc, Amneal Pharms Ny, Ani Pharms, Amneal Pharms, Kv Pharm, Nostrum Labs Inc, Whiteworth Town Plsn, Usl Pharma, Zydus Pharms Usa, and Altana, and is included in eighty-seven NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: promethazine hydrochloride

Drug Master File Entries: see list12
Suppliers / Packagers: see list66
Bulk Api Vendors: see list50
Clinical Trials: see list1,003
Patent Applications: see list2,577
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:promethazine hydrochloride at DailyMed

Pharmacology for Ingredient: promethazine hydrochloride

Drug ClassPhenothiazine
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
promethazine hydrochloride
TABLET;ORAL083176-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Watson Labs Inc
promethazine hydrochloride
SUPPOSITORY;RECTAL040479-002Jun 24, 2003ABRXNoNo► Subscribe► Subscribe
promethazine hydrochloride
TABLET;ORAL084233-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Watson Labs
promethazine hydrochloride
TABLET;ORAL083712-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Ivax Sub Teva Pharms
promethazine hydrochloride
TABLET;ORAL083613-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
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  • Formulary management
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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