Blue Phentermine HCl, USP 
PRODUCT DETAIL
 |
NDC #: |
|
|
0185-5000-01 |
| Generic for: |
|
|
Fastin ® |
| Strength: |
|
|
30 mg |
| Form: |
|
|
Capsule |
| Shape: |
|
|
Capsule |
| Color: |
|
|
Blue/Clear |
| Rating: |
|
|
AA |
| Size: |
|
|
100 |
Yellow Phentermine HCl, USP
PRODUCT DETAIL
|
 |
| NDC #: |
|
|
0185-0647-01 |
| Generic for: |
|
|
N/A |
| Strength: |
|
|
30 mg |
| Form: |
|
|
Capsule |
| Shape: |
|
|
Capsule |
| Color: |
|
|
Yellow |
| Rating: |
|
|
AA |
| Size: |
|
|
100 |
|
Quote from the manufacturer
to explain the rating:
Understanding What the Letters Represent
The two principal categories into which multisource drugs have been placed
are indicated by the first letter:
 | A Drug products that are considered to be therapeutically equivalent to
other pharmaceutically equivalent products: | B Drug products that are not at this time considered to be therapeutically
equivalent to other pharmaceutically equivalent product. | |
“A” products for which there are no known or suspected bioequivalence
problems are further designated as follows, depending on dosage form:
| AA- Products in conventional dosage forms not presenting
bioequivalence problems; | AN- Solutions and powders for aerosolization; | AO- Injectable oil solutions; | AP- Injectable aqueous solutions; | AT-Topical products. | | | | |
“A” products for which actual or potential bioequivalence problems
have been resolved with adequate in vivo or in vitro evidence supporting
bioequivalence are designated as follows:
AB Products meeting necessary bioequivalence
requirements. Products will generally be coded AB if a study is submitted
demonstrating bioquivalence. Even though the drug products of distributors and
/or repackagers are not included in the List, they are considered
therapeutically equivalent to the application holder’s drug product if the
application holder’s product if rated AB or is a single source in the List.
The only instance in which a multisource product will be rated AB on the basis
of bioavailability rather than bioequivalence is where the innovator product
is the only one listed under the drug ingredient heading and has completed an
acceptable bioavailability study. However, it does not signify that this
product is therapeutically equivalent to the other drugs under the same
heading. Drugs coded under an ingredient heading are considered
therapeutically equivalent only to the other drugs coded AB under that
heading.
“B” products, for which actual or potential bioequivalence problems
have not been resolved by adequate evidence of bioequivalence, often have a
problem with specific dosage forms rather than with the active ingredients.
These are further designated as follows:
| BC- Extended-release dosage forms (tablets, capsules, injectables); | BD- Active ingredients and dosage forms with documented
bioequivalence problems; | BE- Delayed-release oral dosage forms; | BN- Products in aerosol-nebulizer drug delivery systems; | BP- Active ingredients and dosage forms with potential
bioequivalence problems; | BR- Suppositories or enemas that deliver drugs for systemic
absorption; | BS- Products having drug-standard deficiencies; | BT- Topical products with bioequivalence isssues; | BX- Drug products for which the data are insufficient to determine
therapeutic equivalence; | B*- Drug products requiring further FDA investigation and review to
determine equivalence. | | | | | | | | | |
DESI, (Drug Efficacy Study Implementation) - DESI drugs are those drugs
first marketed between 1938 and 1962 which were approved as safe but required no
showing of effectiveness for FDA product approval. The DESI program subsequently
made a determination of fully effective for most of these products and they
remain in the marketplace.
Grandfathered - Drugs marketed prior to 1938, provided those drugs retain
their exact formulations and were not promoted for new uses.
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