BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for brompheniramine maleate; pseudoephedrine hydrochloride and what is the scope of freedom to operate?

Brompheniramine maleate; pseudoephedrine hydrochloride is the generic ingredient in one branded drug marketed by Alza and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	1
DailyMed Link:	BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

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Sponsor	Phase
Ache Laboratorios Farmaceuticos S.A.	Phase 3

See all BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

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

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

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

R03CA	Alpha- and beta-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R06AB	Substituted alkylamines
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
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

US Patents and Regulatory Information for BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

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Glossary

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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
Alza	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019672-001	Mar 29, 1996		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

Expired US Patents for BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alza	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019672-001	Mar 29, 1996	⤷ Sign Up	⤷ Sign Up
Alza	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019672-001	Mar 29, 1996	⤷ Sign Up	⤷ Sign Up
Alza	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019672-001	Mar 29, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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