Flashcards in Codes For Orange Book Deck (16)
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1
AN
Solutions and powders for aerosolization
2
AO
Injectable Oil solutions
3
AP
Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions
4
AT
Topical Products
5
AB, AB1, AB3,....
These codes a re assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading
6
What are A codes?
Products for which actual or potential bioequivalence problems have been resolved with adequate in vivo and/or vitro evidence supporting bioquivalence
7
B codes
Products, for which actual or potential bioquivalence problems have not been resolved by adequate evidence of bioequivalnce, often have problem with specific dosage forms rather than with the active ingredients
8
BE
Delayed-release oral dosage forms
9
BN
Products in aerosol-nebulizer drug delivery systems
10
BR
Suppositories or enemas that deliver drugs for systemic absorption
11
BT
Topical products with bioequivalence issues
12
BX
Drug products for which the data are insufficient to determine therapeutic equivalence
13
What is a class 1 BCS drug?
High solubility
High Permeability
14
What are class 2 drugs of BCS
Low Solubility
High Permeability
Dissolution limited
15
What are class 3 drugs of BCS system
High solubility
Low Permeability
Permeability limited
16