Therapeutic Equivalence Evaluation Codes

Question 1

A Codes – Definition

Answer 1

Drug products considered to be therapeutically equivalent to other pharmaceutically equivalent products.

Question 2

AA Code

Answer 2

Products in conventional dosage forms not presenting bioequivalence problems.

Question 3

AB Code

Answer 3

Products meeting bioequivalence requirements.

Question 4

AN Code

Answer 4

Solutions and powders for aerosolization.

Question 5

AO Code

Answer 5

Injectable oil solutions.

Question 6

AP Code

Answer 6

Injectable aqueous solutions.

Question 7

AT Code

Answer 7

Topical products.

Question 8

B Codes – Definition

Answer 8

Drug products that the FDA does not consider therapeutically equivalent to other pharmaceutically equivalent products.

Question 9

B Code*

Answer 9

Drug products requiring further FDA investigation to determine therapeutic equivalence.

Question 10

BC Code

Answer 10

Extended-release tablets, capsules, and injectables.

Question 11

BD Code

Answer 11

Active ingredients and dosage forms with documented bioequivalence problems.

Question 12

BE Code

Answer 12

Delayed-release oral dosage forms.

Question 13

BN Code

Answer 13

Products in aerosol–nebulizer drug delivery systems.

Question 14

BP Code

Answer 14

Active ingredients and dosage forms with potential bioequivalence problems.

Question 15

BR Code

Answer 15

Suppositories or enemas for systemic use.

Question 16

BS Code

Answer 16

Products having drug standard deficiencies.

Question 17

BT Code

Answer 17

Topical products with bioequivalence issues.

Question 18

BX Code

Answer 18

Insufficient data to determine therapeutic equivalence.