FDA Orange Book · active-ingredient family
Methamphetamine hydrochloride
Methamphetamine hydrochloride is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DESOXYN · NDA 005378
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DESOXYNRLD×4 | AJENAT PHARMS | NDA 005378 | AA | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METHAMPHETAMINE HYDROCHLORIDE | HIKMA | ANDA 203846 | AA | Nov 17, 2015 | |
| METHAMPHETAMINE HYDROCHLORIDE | DR REDDYS LABS SA | ANDA 091189 | AA | Apr 21, 2010 | |
| METHAMPHETAMINE HYDROCHLORIDE | ABLE | ANDA 040529 | — | Feb 25, 2004 | |
| METHAMPEX | TEVA | ANDA 083889 | — | Approved Prior to Jan 1, 1982 | |
| METHAMPHETAMINE HYDROCHLORIDE×2 | REXAR | ANDA 084931 | — | Approved Prior to Jan 1, 1982 | |
| METHAMPHETAMINE HYDROCHLORIDE | TEVA | ANDA 086359 | — | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Methamphetamine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
