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Status:
Possibly Marketed Outside US
Source:
ANDA084114
(1974)
Source URL:
First approved in 1974
Source:
ANDA084114
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(1974)
Source:
BLA050114
(1974)
Source URL:
First approved in 1974
Source:
BLA050114
Source URL:
Class:
POLYMER
Conditions:
Benzylpenicilloyl Polylysine is a skin-testing reagent which used to detect immunoglobulin E antibodies in people with a history of penicillin allergy. The quantitation of in vitro IgE antibodies to the benzylpenicilloyl determinant is a useful tool for evaluating allergic subjects.
A penicillin skin test predicts only the presence of IgE antibodies for the major or minor penicillin determinants at the time of application and does not predict the future development of IgE-mediated reactions during subsequent courses of penicillin. Benzylpenicilloyl polylysine reacts specifically with penicilloyl skin sensitizing antibodies (reagins) to produce immediate wheal and flare reactions which may reflect increased risk of allergic reactions to subsequent penicillin therapy. The use of benzylpenicilloyl polylysine can detect between 75-90% of all positive reactions to penicillin. Benzylpenicilloyl polylysine was FDA approved in 2009 for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in those patients suspected of having a clinical hypersensitivity to penicillin.
Status:
US Approved OTC
Source:
21 CFR 349.12(a)(3) ophthalmic:demulcents hypromellose
Source URL:
First approved in 1974
Source:
NDA050754
Source URL:
Class:
POLYMER
Status:
US Approved OTC
Source:
21 CFR 349.12(a)(3) ophthalmic:demulcents hypromellose
Source URL:
First approved in 1974
Source:
NDA200890
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
First approved in 1974
Source:
E-Z-Paste by E-Z-EM Canada Inc
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
ANDA090931
(1997)
Source URL:
First approved in 1974
Source:
NDA050813
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 358A
(1974)
Source URL:
First approved in 1974
Source:
21 CFR 358A
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
First approved in 1974
Source:
Nupro Fluorides NaF Oral Solution Mint by Dentsply LLC. Professional Division Trading as DENTSPLY Professional
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
First approved in 1974
Source:
E-Z-Paste by E-Z-EM Canada Inc
Source URL:
Class:
POLYMER
Status:
US Approved Allergenic Extract
(1974)
Source:
BLA102223
(1974)
Source URL:
First approved in 1974
Source:
BLA102223
Source URL:
Class:
STRUCTURALLY DIVERSE