FDA Orange Book · active-ingredient family
Diethylpropion hydrochloride
Diethylpropion hydrochloride is approved as 6 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TENUATE DOSPAN · NDA 012546
6
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TENUATE DOSPANRLD | ANI PHARMS | NDA 012546 | — | Approved Prior to Jan 1, 1982 | |
| TENUATERLD | MPP PHARMA | NDA 011722 | — | Approved Prior to Jan 1, 1982 | |
| TENUATE | SANOFI AVENTIS US | NDA 017669 | — | Approved Prior to Jan 1, 1982 | |
| TEPANIL TEN-TAB | 3M | NDA 017956 | — | Approved Prior to Jan 1, 1982 | |
| TENUATE | SANOFI AVENTIS US | NDA 017668 | — | Approved Prior to Jan 1, 1982 | |
| TEPANIL | 3M | NDA 011673 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIETHYLPROPION HYDROCHLORIDE | LANNETT CO INC | ANDA 091680 | — | Oct 24, 2011 | |
| DIETHYLPROPION HYDROCHLORIDE | LANNETT CO INC | ANDA 200177 | AA | Jul 18, 2011 | |
| DIETHYLPROPION HYDROCHLORIDE | AVANTHI INC | ANDA 201212 | AA | Dec 22, 2010 | |
| DIETHYLPROPION HYDROCHLORIDE | EPIC PHARMA LLC | ANDA 040828 | — | Nov 05, 2008 | |
| DIETHYLPROPION HYDROCHLORIDE | TEVA | ANDA 088642 | — | Sep 20, 1984 | |
| DIETHYLPROPION HYDROCHLORIDE | CHARTWELL RX | ANDA 088267 | — | Aug 25, 1983 | |
| DIETHYLPROPION HYDROCHLORIDE | CHARTWELL RX | ANDA 088268 | — | Aug 25, 1983 | |
| DIETHYLPROPION HYDROCHLORIDE | SANDOZ | ANDA 085916 | — | Approved Prior to Jan 1, 1982 | |
| DIETHYLPROPION HYDROCHLORIDE | UCB INC | ANDA 085544 | — | Approved Prior to Jan 1, 1982 | |
| DIETHYLPROPION HYDROCHLORIDE | WATSON LABS | ANDA 085741 | — | 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.
Diethylpropion hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
