Orange Book product · Brand (NDA)
IMITREX STATDOSE
SUMATRIPTAN SUCCINATE
At a glance
Dec 23, 1996
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 23, 1996
29 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
SUMATRIPTAN SUCCINATE
Strength
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Dosage form
INJECTABLE
Route
SUBCUTANEOUS
TE code
AB
Application
NDA 020080
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.
- 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.
