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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

What are class 4 BCS drugs

Low Solubility

Low Permeability

Not a very good drug