Orange Book product · Brand (NDA)
RAZADYNE ER
GALANTAMINE HYDROBROMIDE
At a glance
Apr 01, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 01, 2005
21 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
GALANTAMINE HYDROBROMIDE
Strength
EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 021615
Product number
003
Marketing status
DISCN
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.
- 2001RAZADYNEBrand (NDA)
NDA 021224 · JANSSEN PHARMS
- 2001RAZADYNEBrand (NDA)
NDA 021169 · JANSSEN PHARMS
- 2016GALANTAMINE HYDROBROMIDEGeneric (ANDA)
ANDA 204895 · AUROBINDO PHARMA
- 2011GALANTAMINE HYDROBROMIDEGeneric (ANDA)
ANDA 077781 · APOTEX INC
- 2011GALANTAMINE HYDROBROMIDEGeneric (ANDA)
ANDA 090957 · AUROBINDO PHARMA LTD
- 2011GALANTAMINE HYDROBROMIDEGeneric (ANDA)
ANDA 078898 · ZYDUS PHARMS USA INC
- 2011GALANTAMINE HYDROBROMIDEGeneric (ANDA)
ANDA 090178 · SUN PHARM
- 2011GALANTAMINE HYDROBROMIDEGeneric (ANDA)
ANDA 090900 · PHARMOBEDIENT
- 2009GALANTAMINE HYDROBROMIDEGeneric (ANDA)
ANDA 077585 · HERITAGE PHARMA
- 2009GALANTAMINE HYDROBROMIDEGeneric (ANDA)
ANDA 077587 · CHARTWELL RX
- 2009GALANTAMINE HYDROBROMIDEGeneric (ANDA)
ANDA 077589 · SANDOZ
- 2009GALANTAMINE HYDROBROMIDEGeneric (ANDA)
ANDA 077590 · MYLAN
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.
