Orange Book product · Brand (NDA)
ZOMIG-ZMT
ZOLMITRIPTAN
At a glance
Feb 13, 2001
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 13, 2001
25 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ZOLMITRIPTAN
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
Not listed
Application
NDA 021231
Product number
001
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.
- 2013ZOMIGBrand (NDA)
NDA 021450 · AMNEAL
- 1997ZOMIGBrand (NDA)
NDA 020768 · IPR
- 2021ZOLMITRIPTANGeneric (ANDA)
ANDA 212469 · PADAGIS ISRAEL
- 2019ZOLMITRIPTANGeneric (ANDA)
ANDA 203726 · ORBION PHARMS
- 2019ZOLMITRIPTANGeneric (ANDA)
ANDA 202855 · RISING
- 2018ZOLMITRIPTANGeneric (ANDA)
ANDA 203019 · ZYDUS PHARMS
- 2017ZOLMITRIPTANGeneric (ANDA)
ANDA 206973 · CHARTWELL RX
- 2017ZOLMITRIPTANGeneric (ANDA)
ANDA 207867 · PLD ACQUISITIONS LLC
- 2016ZOLMITRIPTANGeneric (ANDA)
ANDA 205074 · ALEMBIC
- 2016ZOLMITRIPTANGeneric (ANDA)
ANDA 204041 · AJANTA PHARMA LTD
- 2016ZOLMITRIPTANGeneric (ANDA)
ANDA 207021 · AUROBINDO PHARMA
- 2015ZOLMITRIPTANGeneric (ANDA)
ANDA 204336 · MACLEODS PHARMS LTD
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.
