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Search results for ranitidine in Code Comments (approximate match)
Showing 1 - 3 of 3 results
Status:
US Approved Rx
(2007)
Source:
ANDA077405
(2007)
Source URL:
First approved in 1983
Source:
ZANTAC 150 by GLAXO GRP LTD
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Ranitidine, a histamine H2-receptor antagonist, is now well established as a potent inhibitor of gastric acid secretion effective in the treatment and prophylaxis of gastrointestinal lesions aggravated by gastric acid secretion.
Status:
US Approved OTC
Source:
21 CFR 331.11(c)(3) antacid:bismuth-containing bismuth subcarbonate
Source URL:
First marketed in 1892
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Bibrocathol (trade names Noviform and Posiformin) is a well-established topical antiseptic for the treatment of acute eyelid diseases like blepharitis. Eye ointments containing 2 or 5 % bibrocathol and the excipients liquid paraffin, white soft paraffin, and lanolin have been marketed since 1967 for the treatment of eye irritation, chronic blepharitis, and uninfected corneal injuries. Reports of clinical experience with bibrocathol for inflammation of the edge of the palpebra exist since the beginning of the 20th century. Until recently, no controlled, randomized clinical studies according to the guidelines for Good Clinical Practice for Trials on Medical Products for Human Use (GCP) as defined by the International Conference on Harmonisation (ICH) have been performed with bibrocathol 2 % ointment, as these were not required for marketing authorization in the 1960s. A first double-blind, prospective, controlled, GCP-compliant clinical study was recently performed to assess the efficacy of bibrocathol 5 % (Noviform®) in acute blepharitis. It demonstrated superior efficacy of bibrocathol 5 % ointment as compared to an ointment vehicle (placebo) after 2 weeks of treatment as assessed by a combined measure of slit-lamp examination results and patients’ subjective complaints.
Status:
US Approved Rx
(2007)
Source:
ANDA077405
(2007)
Source URL:
First approved in 1983
Source:
ZANTAC 150 by GLAXO GRP LTD
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Ranitidine, a histamine H2-receptor antagonist, is now well established as a potent inhibitor of gastric acid secretion effective in the treatment and prophylaxis of gastrointestinal lesions aggravated by gastric acid secretion.