Orange Book product · Brand (NDA)
ZOMIG
ZOLMITRIPTAN
At a glance
Sep 16, 2013
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 16, 2013
12 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
ZOLMITRIPTAN
Strength
2.5MG/SPRAY
Dosage form
SPRAY
Route
NASAL
TE code
AB
Application
NDA 021450
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2001ZOMIG-ZMTBrand (NDA)
NDA 021231 · ASTRAZENECA
- 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.
