FDA Orange Book · active-ingredient family
Reserpine
Reserpine is approved as 17 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:RESERPINE · NDA 009838
17
Brand (NDA)
23
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · elixir, injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RESERPINERLD×2 | SANDOZ | NDA 009838 | — | Approved Prior to Jan 1, 1982 | |
| SERPASIL×4 | NOVARTIS | NDA 009115 | — | Approved Prior to Jan 1, 1982 | |
| SANDRIL | LILLY | NDA 010012 | — | Approved Prior to Jan 1, 1982 | |
| SERPASIL | NOVARTIS | NDA 009434 | — | Approved Prior to Jan 1, 1982 | |
| HISERPIA×2 | BOWMAN PHARMS | NDA 009631 | — | Approved Prior to Jan 1, 1982 | |
| RAU-SED×4 | BRISTOL MYERS SQUIBB | NDA 009357 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE×2 | BUNDY | NDA 009663 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE×2 | CYCLE | NDA 009859 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE×4 | EVERYLIFE | NDA 010441 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE×2 | IMPAX LABS | NDA 009627 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE×2 | IVAX SUB TEVA PHARMS | NDA 011185 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE×2 | VALEANT PHARM INTL | NDA 009667 | — | Approved Prior to Jan 1, 1982 | |
| SANDRIL×2 | LILLY | NDA 009376 | — | Approved Prior to Jan 1, 1982 | |
| SERPALAN×2 | LANNETT | NDA 010124 | — | Approved Prior to Jan 1, 1982 | |
| SERPANRAY×3 | PANRAY | NDA 009391 | — | Approved Prior to Jan 1, 1982 | |
| SERPATE×2 | VALE | NDA 009453 | — | Approved Prior to Jan 1, 1982 | |
| SERPIVITE | VITARINE | NDA 009645 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (23)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RESERPINE | TEVA | ANDA 089020 | — | Mar 07, 1985 | |
| RESERPINE | TEVA | ANDA 089019 | — | Mar 07, 1985 | |
| RESERPINE | BARR | ANDA 080721 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE×2 | BELL PHARMA | ANDA 083058 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE×2 | ELKINS SINN | ANDA 083145 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE×3 | HALSEY | ANDA 080457 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE×3 | HIKMA INTL PHARMS | ANDA 080975 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE×2 | MARSHALL PHARMA | ANDA 080492 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE×2 | MK LABS | ANDA 080525 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE | MYLAN | ANDA 084974 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE | PHARMAVITE | ANDA 084663 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE×2 | PUREPAC PHARM | ANDA 080753 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE | PVT FORM | ANDA 086117 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE×2 | PVT FORM | ANDA 080582 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE | PVT FORM | ANDA 085775 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE | REXALL | ANDA 080637 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE | SOLVAY | ANDA 080446 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE | TABLICAPS | ANDA 085207 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE | WATSON LABS | ANDA 080679 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE | WATSON LABS | ANDA 080393 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE | WATSON LABS | ANDA 085401 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE | WATSON LABS | ANDA 080749 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE×3 | WHITEWORTH TOWN PLSN | ANDA 080723 | — | 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.
Reserpine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

