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Last Updated: November 21, 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, 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-nine 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:	49
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	58
Patent Applications:	4,150
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

Sponsor	Phase
National Trauma Center	N/A
Oman Medical Speciality Board	Phase 3
Tanta University	N/A

See all promethazine hydrochloride clinical trials

Pharmacology for promethazine hydrochloride

Drug Class	Phenothiazine

Medical Subject Heading (MeSH) Categories for promethazine hydrochloride

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for promethazine hydrochloride

D04AA	Antihistamines for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

R06AD	Phenothiazine derivatives
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for promethazine hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	085684-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	INJECTABLE;INJECTION	083312-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Able	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	040558-002	Jul 1, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms Usa	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	040596-001	Nov 18, 2005	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cosette	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	SUPPOSITORY;RECTAL	040428-001	Feb 5, 2002	AB	RX	No	Yes	⤷ 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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