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Old 05-24-12, 02:08 AM
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Re: Anyone fill barr-teva lately?

There is an FDA resource that maintains lists of all approved generic drugs and call it 'the orange book' and can tell us if various tablets sold as 'amphetamine salts' are approved generics to adderall. Below are my findings when searching for FDA approved generics to adderall:

Quote:
Originally Posted by orange book

Searched for Adderall
N021303
RLD:No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL 2.5MG;2.5MG;2.5MG;2.5MG ADDERALL XR 10 SHIRE

N021303
RLD:No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL 3.75MG;3.75MG;3.75MG;3.75MG ADDERALL XR 15 SHIRE

N021303
RLD:No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL 5MG;5MG;5MG;5MG ADDERALL XR 20 SHIRE

N021303
RLD:No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL 6.25MG;6.25MG;6.25MG;6.25MG ADDERALL XR 25 SHIRE

N021303
RLD:Yes AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL 7.5MG;7.5MG;7.5MG;7.5MG ADDERALL XR 30 SHIRE

N021303
RLD:No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE; ORAL 1.25MG;1.25MG;1.25MG;1.25MG ADDERALL XR 5 SHIRE
Searched for Medications containing Amphetamine salts
A040422 RLD:
Yes AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 7.5MG;7.5MG;7.5MG;7.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE BARR

A040422 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 1.25MG;1.25MG;1.25MG;1.25MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE BARR
A040422 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 1.875MG;1.875MG;1.875MG;1.875MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE BARR
A040422 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 2.5MG;2.5MG;2.5MG;2.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE BARR
A040422 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 3.125MG;3.125MG;3.125MG;3.125MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE BARR
A040422 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 3.75MG;3.75MG;3.75MG;3.75MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE BARR
A040422 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 5MG;5MG;5MG;5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE BARR
A040444 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 1.25MG;1.25MG;1.25MG;1.25MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE COREPHARMA
A040444 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 2.5MG;2.5MG;2.5MG;2.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE COREPHARMA
A040444 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 5MG;5MG;5MG;5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE COREPHARMA
A040444 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 7.5MG;7.5MG;7.5MG;7.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE COREPHARMA
A040439 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 1.25MG;1.25MG;1.25MG;1.25MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE SANDOZ
A040439 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 2.5MG;2.5MG;2.5MG;2.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE SANDOZ
A040439 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 5MG;5MG;5MG;5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE SANDOZ
A040439 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 7.5MG;7.5MG;7.5MG;7.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE SANDOZ
A040472 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 1.25MG;1.25MG;1.25MG;1.25MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE TEVA PHARMS
A040472 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 2.5MG;2.5MG;2.5MG;2.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE TEVA PHARMS
A040472 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 5MG;5MG;5MG;5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE TEVA PHARMS
A040472 RLD: No AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL 7.5MG;7.5MG;7.5MG;7.5MG DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE TEVA PHARMS


I bolded the RLD(Reference Listed Drug) in the above examples because this seems very important. The definition of this is in quotes below. This would seem to indicate that only one of the above listed results is actually a recognized Generic of adderall and all others in the list are all brand name since they lack an RLD. All other drugs containing a mix of amphetamine salts that are not listed are not FDA Approved as actual generics for adderall and are being sold as 'amphetamine salts' and are not necessarily equivalent to adderall in its absorption and effectiveness. This seems to indicate that ONLY BARR produced 'amphetamine salts' is approved to be called ADDERALL GENERIC. This could finally explain why there is so much debate surrounding which manufacturers 'generic' is the closest to name brand adderall. I may be interpreting this wrong so by all means if anyone can weigh in on this I think it will help the discussion.

Quote:
Originally Posted by RLD
A reference listed drug (21 CFR 314.94(a)(3)) means the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its ANDA(generic drug labeling).
FDA has identified in the Prescription Drug Product and OTC Drug Product Lists those reference listed drugs to which the in vivo bioequivalence (reference standard) and, in some instances, the in vitro bioequivalence of the applicant's product is compared. By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. Such variations could result if generic drugs were compared to different reference listed drugs. However, in some instances when listed drugs are approved for a single drug product, a product not designated as the reference listed drug and not shown to be bioequivalent to the reference listed drug may be shielded from generic competition. A firm wishing to market a generic version of a listed drug that is not designated as the reference listed drug may petition the Agency through the Citizen Petition procedure (see 21 CFR 10.25(a) and CFR 10.30). When the Citizen Petition is approved, the second listed drug will be designated as an additional reference listed drug and the petitioner may submit an Abbreviated New Drug Application citing the designated reference listed drug. Therapeutic Equivalence Evaluations Codes Products meeting necessary bioequivalence requirements explains the AB, AB1, AB2, AB3coding system for multisource drug products listed under the same heading with two reference listed drugs.


TL;DR = ONLY BARR is producing approved generics for branded adderall.
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