Orange Book product · Brand (NDA)
IMITREX STATDOSE
SUMATRIPTAN SUCCINATE
At a glance
Feb 01, 2006
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 01, 2006
20 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
SUMATRIPTAN SUCCINATE
Strength
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
Dosage form
INJECTABLE
Route
SUBCUTANEOUS
TE code
AB
Application
NDA 020080
Product number
002
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.
- 2016ZEMBRACE SYMTOUCHBrand (NDA)
NDA 208223 · TONIX MEDS
- 2016ONZETRA XSAILBrand (NDA)
NDA 206099 · CURRAX
- 2013SUMAVEL DOSEPROBrand (NDA)
NDA 022239 · ENDO OPERATIONS
- 2013ZECUITYBrand (NDA)
NDA 202278 · TEVA BRANDED PHARM
- 2010ALSUMABrand (NDA)
NDA 022377 · MERIDIAN MEDCL
- 1995IMITREXBrand (NDA)
NDA 020132 · GLAXOSMITHKLINE
- 2025SUMATRIPTAN SUCCINATEGeneric (ANDA)
ANDA 213518 · ALEMBIC
- 2025SUMATRIPTAN SUCCINATEGeneric (ANDA)
ANDA 206019 · IPCA LABS LTD
- 2024SUMATRIPTAN SUCCINATEGeneric (ANDA)
ANDA 219036 · VKT PHARMA
- 2024SUMATRIPTAN SUCCINATEGeneric (ANDA)
ANDA 215651 · ONESOURCE SPECIALTY
- 2023SUMATRIPTAN SUCCINATEGeneric (ANDA)
ANDA 207101 · BAXTER HLTHCARE CORP
- 2021SUMATRIPTAN SUCCINATEGeneric (ANDA)
ANDA 213998 · CAPLIN
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.
