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Last Updated: June 2, 2020

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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 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, Acp Nimble, Perrigo Israel, Taro, Watson Labs Inc, Usl Pharma, Alpharma Us Pharms, Actavis Mid Atlantic, Cenci, Amneal Pharms, Hi Tech Pharma, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Tris Pharma Inc, Vintage, Whiteworth Town Plsn, Ani Pharms, Wockhardt Bio Ag, Delcor Asset Corp, Amneal Pharms Ny, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, Lannett, Prinston Inc, Pvt Form, Quagen, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, and Bristol Myers Squibb, and is included in eighty-seven NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for PROMETHAZINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Alabama at BirminghamPhase 4
Hopital Psychiatrique De La CroixPhase 4
University of NottinghamPhase 4

See all PROMETHAZINE HYDROCHLORIDE clinical trials

Pharmacology for PROMETHAZINE HYDROCHLORIDE
Drug ClassPhenothiazine
Medical Subject Heading (MeSH) Categories for PROMETHAZINE HYDROCHLORIDE
Synonyms for PROMETHAZINE HYDROCHLORIDE
(+-)-10-(2-(Dimethylamino)propyl)phenothiazine monohydrochloride
10-(2-(Dimethylamino)propyl)phenothiazine monohydrochloride
10-(2-Dimethylamino-1-propyl)phenothiazine hydrochloride
10-(2-Dimethylaminopropyl)phenothiazine hydrochloride
10-(3-dimethylaminoisoprop yl)phenothiazine hydrochloride
10-(3-Dimethylaminoisopropyl)phenothiazine hydrochloride
10-[2-(Dimethylamino)propyl]phenothiazine hydrochloride
10H-Phenothiazine-10-ethanamine, N,N,.alpha.-trimethyl-, hydrochloride (1:1)
10H-Phenothiazine-10-ethanamine, N,N,alpha-trimethyl-, hydrochloride (1:1)
10H-Phenothiazine-10-ethanamine, N,N,alpha-trimethyl-, monohydrochloride
10H-Phenothiazine-10-ethanamine, N,N,alpha-trimethyl-, monohydrochloride, (+-)-
10H-Phenothiazine-10-ethanamine,N,.alpha.-trimethyl-, monohydrochloride
3277 R.P
3277 R.P.
58-33-3
A831833
AB0013086
AC-12482
AK163688
AKOS016339657
Allerfen
Anergan 25
Anergan 50
API0003942
Atosil
AX8055660
BBC/878
Bonnox
CAS-58-33-3
CCG-207895
CCRIS 5873
CHEBI:8462
CHEMBL1200750
Closin
component of Mepergan
CPD000058379
CS-3543
CTK8G2592
D00480
DB-053186
DIMETHYL[1-(10H-PHENOTHIAZIN-10-YL)PROPAN-2-YL]AMINE HYDROCHLORIDE
Diprasine
Diprazin
Dorme
DSSTox_CID_1192
DSSTox_GSID_21192
DSSTox_RID_76002
DTXSID3021192
Duplamin
EINECS 200-375-2
EU-0100899
Eusedon Mono
F0138-3355
Farganesse
Fellozine
Fenergan
Frinova
FT-0631258
Ganphen
Goodnight
H509
Hibechin
Histantil
HL 8700
HMS1570B18
HMS1920L16
HY-B0781
J10089
Kinetosin
KS-0000129F
KS-1385
Lergigan
LP00899
LS-40
MCULE-6615710182
MFCD00012652
MLS000069398
MLS001074184
MLS002548850
Mymethazine Fortis
N-(2-dimethylaminoprop-1-yl)phenothiazine hydrochloride
N-(2-Dimethylaminopropyl-1)phenothiazine hydrochloride
N-(2'-Dimethylamino-2-methylethyl)phenothiazine hydrochloride
N-(2'-Dimethylamino-2'-methyl)ethylphenothiazine hydrochloride
N-(2'-Dimethylamino-2'-methylaethyl)-phenothiazin hydrochlorid
N-(2'-dimethylamino-2'-methylethyl)phenothiazine hydrochlor ide
N-(2'-dimethylamino-2'-methylethyl)phenothiazine hydrochloride
N,N-dimethyl-1-(10-phenothiazinyl)-2-propanamine hydrochloride
N,N-dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine hydrochloride
N,N-Dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine--hydrogen chloride (1/1)
N,N-dimethyl-1-phenothiazin-10-yl-propan-2-amine hydrochloride
N,N-dimethyl-1-phenothiazin-10-ylpropan-2-amine;hydrochloride
N,N,alpha-trimethyl-10H-phenothiazine-10-ethanamine monohydrochloride
NC00471
NCGC00089735-04
NCGC00094215-01
NCGC00094215-02
NCGC00094215-03
NCGC00094215-04
NCGC00094215-05
NCGC00256588-01
NCGC00259813-01
NCGC00261584-01
NSC 231688
NSC-231688
NSC-757301
NSC231688
NSC757301
Opera_ID_1745
P 4651
P2029
Pharmakon1600-01500510
Phenadoz
Phencen
Phenergan
Phenergan (TN)
Phenergan Fortis
Phenergan hydrochloride
PHENERGAN PLAIN
Phenothiazine, 10-(2-(dimethylamino)-propyl)-, hydrochloride
Phenothiazine, 10-(2-(dimethylamino)propyl)-, monohydrochloride
Phergan
Pipolfen
Pipolphen
Plletia
PMS Promethazine
prim ine
Primine
Promantine
Prome
Prometh Fortis
Prometh Plain
Promethazine (hydrochloride)
Promethazine chloride
Promethazine for peak identification, European Pharmacopoeia (EP) Reference Standard
Promethazine Hcl
Promethazine hydrochloride (JP17/USP)
PROMETHAZINE HYDROCHLORIDE (SEE ALSO PROMETHAZINE 60-87-7)
Promethazine hydrochloride [JAN]
Promethazine hydrochloride [USP:JAN]
Promethazine Hydrochloride 1.0 mg/ml in Dimethyl Sulfoxide (as free base)
Promethazine hydrochloride, European Pharmacopoeia (EP) Reference Standard
Promethazine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Promethazine hydrochloride, United States Pharmacopeia (USP) Reference Standard
Promethazine hydrochloride, VETRANAL(TM), analytical standard
Promethazine hydrochloride, vial of 25 mg, certified reference material
Promethazine Hydrochloride,(S)
Promethazine hydrochlorine
Promethazine monohydrochloride
Promethazine Plain
promethazine-hcl
Promethazine.HCl
PromethazineHydrochloride
Promethegan (TN)
Promethiazin
Promethiazin [German]
Promine
Proneurin
Prothazine
Pyrethia
Q27108086
Remsed
Romergan
s4293
SAM002264636
SC-19551
SCHEMBL41904
SMR000058379
Sominex
Soporil
SPECTRUM1500510
SR-01000002993
SR-01000002993-2
SR-01000002993-7
ST24048193
ST51015100
SW197234-3
Tox21_202264
Tox21_302878
Tox21_500899
TRA0003095
V GAN
Vallgerine
W-105399
WLN: T C666 BN ISJ B1Y1&N1&1 &GH
XXPDBLUZJRXNNZ-UHFFFAOYSA-N
Z1259273234
Zipan-25
ZIPAN-50

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
Altana ZIPAN-25 promethazine hydrochloride INJECTABLE;INJECTION 083997-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Polymedica PROMETHACON promethazine hydrochloride SUPPOSITORY;RECTAL 084901-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Acp Nimble PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SUPPOSITORY;RECTAL 040428-001 Feb 5, 2002 AB RX No Yes   Start Trial   Start Trial   Start Trial
Watson Labs PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET;ORAL 083712-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride INJECTABLE;INJECTION 040372-002 Jun 8, 2000 DISCN No No   Start Trial   Start Trial   Start 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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Express Scripts
Harvard Business School
Dow
Medtronic

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