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Last Updated: November 12, 2024

PROMETHAZINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug 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, Hikma, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, Wockhardt, Xgen Pharms, Altana, Norvium Bioscience, 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. Forty-eight suppliers are listed for this compound.

Summary for PROMETHAZINE HYDROCHLORIDE
US Patents:0
Tradenames:13
Applicants:54
NDAs:89
Drug Master File Entries: 8
Finished Product Suppliers / Packagers: 48
Raw Ingredient (Bulk) Api Vendors: 94
Clinical Trials: 58
Patent Applications: 4,772
What excipients (inactive ingredients) are in PROMETHAZINE HYDROCHLORIDE?PROMETHAZINE HYDROCHLORIDE excipients list
DailyMed Link:PROMETHAZINE HYDROCHLORIDE at DailyMed
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
Amneal Pharms Ny PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 091179-003 Dec 13, 2010 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience PHENERGAN promethazine hydrochloride SUPPOSITORY;RECTAL 010926-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Delcor Asset Corp PHENERGAN promethazine hydrochloride TABLET;ORAL 007935-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 209177-001 Jun 30, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Kv Pharm PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SYRUP;ORAL 085388-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Kv Pharm PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SYRUP;ORAL 085385-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Mid Atlantic PROMETH PLAIN promethazine hydrochloride SYRUP;ORAL 085953-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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