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Last Updated: April 13, 2024

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, Am Regent, Bedford Labs, Epic Pharma Llc, 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, Chartwell Rx, 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, Aurobindo Pharma Usa, 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-one 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
National Trauma CenterN/A
Oman Medical Speciality BoardPhase 3
Tanta UniversityN/A

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
Teva PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 089109-001 Sep 10, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbott PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 084539-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 083403-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbott PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 084166-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cosette PROMETHEGAN promethazine hydrochloride SUPPOSITORY;RECTAL 087165-001 Aug 14, 1987 RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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