Therapeutic Equivalence Codes Flashcards
1
Q
A Codes
A
- Therapeutic equivalence
2
Q
AA
A
- No bioequivalence problems in conventional dosages
3
Q
AB
A
- Meeting necessary bioequivalence requirements
4
Q
AO
A
- Injectable oil solutions
5
Q
AP
A
- Injectable aqueous solutions
6
Q
AT
A
- Topical products
7
Q
B Codes
A
- Products that the FDA doesn’t want to consider therapeutically equivalent to pharmaceutically equivalent products
8
Q
BC
A
- Controlled release tablets, controlled capsules, and controlled release injectables
9
Q
BD
A
- Active ingredients and dosage forms with documented bioequivalence problems
10
Q
BR
A
- Suppositories or enemas for systemic use
11
Q
BS
A
- Products having standard deficiencies
12
Q
BT
A
- Topical products
13
Q
BX
A
- Insufficient data, not presumed to be therapeutically equivalent
