NDC 49502-251

SEMGLEE

Insulin Glargine-yfgn

SEMGLEE is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Specialty L.p.. The primary component is Insulin Glargine.

Product ID49502-251_07c27823-59b9-4d2a-978f-eb95220fbbd9
NDC49502-251
Product TypeHuman Prescription Drug
Proprietary NameSEMGLEE
Generic NameInsulin Glargine-yfgn
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2021-11-15
Marketing CategoryBLA /
Application NumberBLA761201
Labeler NameMylan Specialty L.P.
Substance NameINSULIN GLARGINE
Active Ingredient Strength100 [iU]/mL
Pharm ClassesInsulin [CS],Insulin Analog [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 49502-251-35

1 SYRINGE in 1 CARTON (49502-251-35) > 3 mL in 1 SYRINGE
Marketing Start Date2022-10-01
NDC Exclude FlagN
Sample Package?Y

Drug Details

NDC Crossover Matching brand name "SEMGLEE" or generic name "Insulin Glargine-yfgn"

NDCBrand NameGeneric Name
49502-195SEMGLEEinsulin glargine
49502-196SEMGLEEinsulin glargine
49502-250SEMGLEEinsulin glargine-yfgn
49502-251SEMGLEEinsulin glargine-yfgn
50090-5835SEMGLEEinsulin glargine
49502-393Insulin Glargineinsulin glargine-yfgn
49502-394Insulin Glargineinsulin glargine-yfgn

Trademark Results [SEMGLEE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SEMGLEE
SEMGLEE
88613561 not registered Live/Pending
Mylan Pharmaceuticals, Inc.
2019-09-11
SEMGLEE
SEMGLEE
86970764 not registered Dead/Abandoned
Mylan Pharmaceuticals, Inc.
2016-04-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.