FDA Orange Book · active-ingredient family
Benzphetamine hydrochloride
Benzphetamine hydrochloride is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DIDREX · NDA 012427
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIDREXRLD×2 | PFIZER | NDA 012427 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BENZPHETAMINE HYDROCHLORIDE | EPIC PHARMA LLC | ANDA 090346 | AA | Dec 15, 2015 | |
| BENZPHETAMINE HYDROCHLORIDE×2 | TEDOR PHARM | ANDA 040747 | — | Nov 20, 2015 | |
| BENZPHETAMINE HYDROCHLORIDE | AVET LIFESCIENCES | ANDA 202061 | — | Jan 27, 2012 | |
| BENZPHETAMINE HYDROCHLORIDE×2 | CHARTWELL | ANDA 090473 | — | Sep 15, 2010 | |
| BENZPHETAMINE HYDROCHLORIDE | KVK TECH | ANDA 090968 | AA | Jul 20, 2010 | |
| BENZPHETAMINE HYDROCHLORIDE | IMPAX LABS | ANDA 040845 | — | Nov 18, 2008 | |
| BENZPHETAMINE HYDROCHLORIDE | EPIC PHARMA LLC | ANDA 040714 | — | Oct 29, 2007 | |
| BENZPHETAMINE HYDROCHLORIDE | SPECGX LLC | ANDA 040773 | — | Apr 25, 2007 | |
| BENZPHETAMINE HYDROCHLORIDE | SCINOPHARM TAIWAN | ANDA 040578 | — | Apr 17, 2006 |
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.
Benzphetamine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
