ACTIVE SUBSTANCE / INN

PSEUDOEPHEDRINE SULFATE

Brand name(s): LORATADINE AND PSEUDOEPHEDRINE SULFATE, AFRINOL, RESPORAL, DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE, CLARINEX-D 12 HOUR, CLARITIN-D 24 HOUR, DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DRIXORAL PLUS, BROMPHERIL, CLARITIN-D
FDA LISTED
PRESCRIPTION
OVER-THE-COUNTER
DISCONTINUED
NDA018191
ANDA078366
ACTIVE SUBSTANCE
Pseudoephedrine Sulfate
REGULATORS
FDA
SPONSORS / MAH
ORGANON LLC, PIONEER PHARMS, SUN PHARM INDS LTD
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
CLARITIN-DNDA019670BAYER HEALTHCARE LLCOver-the-counter
CLARITIN-D 24 HOURNDA020470BAYER HEALTHCARE LLCOver-the-counter
LORATADINE AND PSEUDOEPHEDRINE SULFATEANDA076557SUN PHARM INDS LTDOver-the-counter
DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATEANDA078648AVANTHI INCDiscontinued
BROMPHERILANDA089116COPLEY PHARMDiscontinued
CLARINEX-D 12 HOURNDA021313ORGANON LLCPrescription
RESPORALANDA089139PIONEER PHARMSDiscontinued
AFRINOLNDA018191SCHERING PLOUGHDiscontinued
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOURANDA078366DR REDDYS LABS LTDPrescription
DRIXORAL PLUSNDA019453SCHERING PLOUGHDiscontinued

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