Orange Book product · Brand (NDA)
GEODON
ZIPRASIDONE HYDROCHLORIDE
At a glance
Feb 05, 2001
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 05, 2001
25 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ZIPRASIDONE HYDROCHLORIDE
Strength
EQ 80MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 020825
Product number
004
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2006GEODONBrand (NDA)
NDA 021483 · PFIZER INC
- 2017ZIPRASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 208988 · ZYDUS LIFESCIENCES
- 2017ZIPRASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 204375 · MACLEODS PHARMS LTD
- 2016ZIPRASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 204117 · AUROBINDO PHARMA
- 2013ZIPRASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 202395 · MYLAN
- 2012ZIPRASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 090348 · CHARTWELL RX
- 2012ZIPRASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 077562 · SANDOZ INC
- 2012ZIPRASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 077561 · APOTEX
- 2012ZIPRASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 077565 · DR REDDYS LABS INC
- 2012ZIPRASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 077560 · LUPIN PHARMS
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.
