Assyro AI

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

ProductApplicantApplicationTEApproved
RESERPINERLD×2SANDOZNDA 009838Approved Prior to Jan 1, 1982
SERPASIL×4NOVARTISNDA 009115Approved Prior to Jan 1, 1982
SANDRILLILLYNDA 010012Approved Prior to Jan 1, 1982
SERPASILNOVARTISNDA 009434Approved Prior to Jan 1, 1982
HISERPIA×2BOWMAN PHARMSNDA 009631Approved Prior to Jan 1, 1982
RAU-SED×4BRISTOL MYERS SQUIBBNDA 009357Approved Prior to Jan 1, 1982
RESERPINE×2BUNDYNDA 009663Approved Prior to Jan 1, 1982
RESERPINE×2CYCLENDA 009859Approved Prior to Jan 1, 1982
RESERPINE×4EVERYLIFENDA 010441Approved Prior to Jan 1, 1982
RESERPINE×2IMPAX LABSNDA 009627Approved Prior to Jan 1, 1982
RESERPINE×2IVAX SUB TEVA PHARMSNDA 011185Approved Prior to Jan 1, 1982
RESERPINE×2VALEANT PHARM INTLNDA 009667Approved Prior to Jan 1, 1982
SANDRIL×2LILLYNDA 009376Approved Prior to Jan 1, 1982
SERPALAN×2LANNETTNDA 010124Approved Prior to Jan 1, 1982
SERPANRAY×3PANRAYNDA 009391Approved Prior to Jan 1, 1982
SERPATE×2VALENDA 009453Approved Prior to Jan 1, 1982
SERPIVITEVITARINENDA 009645Approved Prior to Jan 1, 1982

Generic (ANDA) products (23)

ProductApplicantApplicationTEApproved
RESERPINETEVAANDA 089020Mar 07, 1985
RESERPINETEVAANDA 089019Mar 07, 1985
RESERPINEBARRANDA 080721Approved Prior to Jan 1, 1982
RESERPINE×2BELL PHARMAANDA 083058Approved Prior to Jan 1, 1982
RESERPINE×2ELKINS SINNANDA 083145Approved Prior to Jan 1, 1982
RESERPINE×3HALSEYANDA 080457Approved Prior to Jan 1, 1982
RESERPINE×3HIKMA INTL PHARMSANDA 080975Approved Prior to Jan 1, 1982
RESERPINE×2MARSHALL PHARMAANDA 080492Approved Prior to Jan 1, 1982
RESERPINE×2MK LABSANDA 080525Approved Prior to Jan 1, 1982
RESERPINEMYLANANDA 084974Approved Prior to Jan 1, 1982
RESERPINEPHARMAVITEANDA 084663Approved Prior to Jan 1, 1982
RESERPINE×2PUREPAC PHARMANDA 080753Approved Prior to Jan 1, 1982
RESERPINEPVT FORMANDA 086117Approved Prior to Jan 1, 1982
RESERPINE×2PVT FORMANDA 080582Approved Prior to Jan 1, 1982
RESERPINEPVT FORMANDA 085775Approved Prior to Jan 1, 1982
RESERPINEREXALLANDA 080637Approved Prior to Jan 1, 1982
RESERPINESOLVAYANDA 080446Approved Prior to Jan 1, 1982
RESERPINETABLICAPSANDA 085207Approved Prior to Jan 1, 1982
RESERPINEWATSON LABSANDA 080679Approved Prior to Jan 1, 1982
RESERPINEWATSON LABSANDA 080393Approved Prior to Jan 1, 1982
RESERPINEWATSON LABSANDA 085401Approved Prior to Jan 1, 1982
RESERPINEWATSON LABSANDA 080749Approved Prior to Jan 1, 1982
RESERPINE×3WHITEWORTH TOWN PLSNANDA 080723Approved 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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.