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Last Updated: March 24, 2023

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, Annora Pharma, 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, Chartwell Molecular, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, 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-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for promethazine hydrochloride. Fifty-three 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
Oman Medical Speciality BoardPhase 3
Tanta UniversityN/A
Beth Israel Deaconess Medical CenterPhase 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
Able PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SUPPOSITORY;RECTAL 040504-001 Apr 11, 2003 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 085986-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Taro PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SYRUP;ORAL 040718-001 Apr 4, 2007 AA RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pvt Form PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 083658-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Impax Labs PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 084214-002 Jul 7, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Kv Pharm PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SYRUP;ORAL 085388-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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Baxter

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