FDA Orange Book · active-ingredient family
Rauwolfia serpentina root
Rauwolfia serpentina root is approved as 11 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:HIWOLFIA · NDA 009276
11
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HIWOLFIA×3 | BOWMAN PHARMS | NDA 009276 | — | Approved Prior to Jan 1, 1982 | |
| HYSERPIN | PHYS PRODS VA | NDA 010581 | — | Approved Prior to Jan 1, 1982 | |
| KOGLUCOID×2 | PANRAY | NDA 009278 | — | Approved Prior to Jan 1, 1982 | |
| RAUDIXIN×2 | APOTHECON | NDA 008842 | — | Approved Prior to Jan 1, 1982 | |
| RAUSERPIN×2 | FERNDALE LABS | NDA 009926 | — | Approved Prior to Jan 1, 1982 | |
| RAUVAL×2 | PAL PAK | NDA 009108 | — | Approved Prior to Jan 1, 1982 | |
| RAUWOLFIA SERPENTINA×2 | BUNDY | NDA 009477 | — | Approved Prior to Jan 1, 1982 | |
| RAUWOLFIA SERPENTINA×2 | IMPAX LABS | NDA 009273 | — | Approved Prior to Jan 1, 1982 | |
| RAUWOLFIA SERPENTINA×2 | IVAX SUB TEVA PHARMS | NDA 011521 | — | Approved Prior to Jan 1, 1982 | |
| RAUWOLFIA SERPENTINA×2 | VALEANT PHARM INTL | NDA 009668 | — | Approved Prior to Jan 1, 1982 | |
| WOLFINA×2 | FOREST PHARMS | NDA 009255 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RAUWOLFIA SERPENTINA×2 | HALSEY | ANDA 080498 | — | Approved Prior to Jan 1, 1982 | |
| RAUWOLFIA SERPENTINA×2 | PUREPAC PHARM | ANDA 080842 | — | Approved Prior to Jan 1, 1982 | |
| RAUWOLFIA SERPENTINA×2 | PVT FORM | ANDA 080583 | — | Approved Prior to Jan 1, 1982 | |
| RAUWOLFIA SERPENTINA×2 | SOLVAY | ANDA 080500 | — | Approved Prior to Jan 1, 1982 | |
| RAUWOLFIA SERPENTINA | TABLICAPS | ANDA 083867 | — | Approved Prior to Jan 1, 1982 | |
| RAUWOLFIA SERPENTINA | TABLICAPS | ANDA 083444 | — | Approved Prior to Jan 1, 1982 | |
| RAUWOLFIA SERPENTINA | WATSON LABS | ANDA 080907 | — | Approved Prior to Jan 1, 1982 | |
| RAUWOLFIA SERPENTINA | WATSON LABS | ANDA 080914 | — | 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.
Rauwolfia serpentina root — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
