Chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride - Generic Drug Details

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What are the generic drug sources for chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride and what is the scope of freedom to operate?

Chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride is the generic ingredient in two branded drugs marketed by Haleon Us Holdings and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
DailyMed Link:	chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride at DailyMed

Pharmacology for chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride

Drug Class	Histamine-1 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug alpha-1 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha1-Agonists Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

C05AX	Other agents for treatment of hemorrhoids and anal fissures for topical use
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

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

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

R06AB	Substituted alkylamines
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01GA	Sympathomimetics used as decongestants
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for chlorpheniramine maleate; ibuprofen; phenylephrine 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
Haleon Us Holdings	ADVIL MULTI-SYMPTOM COLD & FLU	chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022113-002	Apr 28, 2017		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Haleon Us Holdings	ADVIL ALLERGY AND CONGESTION RELIEF	chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022113-001	Dec 21, 2011		OTC	Yes	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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