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ACTIVE SUBSTANCE / INN

ATROPINE SULFATE

Brand name(s): DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE, MOTOFEN HALF-STRENGTH, ATROPINE AND DEMEROL, LOGEN, MOTOFEN, ISOPTO ATROPINE, Ryjunea, MEPERIDINE AND ATROPINE SULFATE, LOMOTIL, ENLON-PLUS
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA020056
NDA017744
ACTIVE SUBSTANCE
Atropine Sulfate
REGULATORS
FDA · EMA
SPONSORS / MAH
WATSON LABS, ALCON LABS INC, GD SEARLE LLC
TOTAL APPLICATIONS
11
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
MEPERIDINE AND ATROPINE SULFATEANDA085121WYETH AYERSTDiscontinued
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEANDA085876WATSON LABSDiscontinued
ENLON-PLUSNDA019678PHARMOBEDIENTDiscontinued
ATROPINE SULFATENDA020056US ARMYDiscontinued
LOMOTILNDA012699GD SEARLE LLCDiscontinued
MOTOFEN HALF-STRENGTHNDA017744LEGACY PHARMADiscontinued
MOTOFENNDA017744LEGACY PHARMAPrescription
ATROPINE AND DEMEROLANDA087853ABBVIEDiscontinued
LOGENANDA088962SUPERPHARMDiscontinued
ISOPTO ATROPINENDA208151ALCON LABS INCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
RyjuneaSanten OyAuthorised02/06/2025Myopia

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