Orange Book product · Brand (NDA)
AMERGE
NARATRIPTAN HYDROCHLORIDE
At a glance
Feb 10, 1998
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 10, 1998
28 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
NARATRIPTAN HYDROCHLORIDE
Strength
EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020763
Product number
002
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.
- 2012NARATRIPTANGeneric (ANDA)
ANDA 202431 · AUROBINDO PHARMA USA
- 2012NARATRIPTANGeneric (ANDA)
ANDA 091441 · ORBION PHARMS
- 2011NARATRIPTANGeneric (ANDA)
ANDA 091373 · APOTEX CORP
- 2011NARATRIPTANGeneric (ANDA)
ANDA 200502 · HERITAGE
- 2011NARATRIPTANGeneric (ANDA)
ANDA 091552 · SUN PHARM INDS LTD
- 2010NARATRIPTANGeneric (ANDA)
ANDA 091326 · PADAGIS US
- 2010NARATRIPTANGeneric (ANDA)
ANDA 078751 · ANI PHARMS
- 2010NARATRIPTANGeneric (ANDA)
ANDA 090288 · CHARTWELL RX
- 2010NARATRIPTANGeneric (ANDA)
ANDA 090381 · HIKMA
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.
