NDC 49502-378

ERMEZA

Levothyroxine Sodium

ERMEZA is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Specialty L.p.. The primary component is Levothyroxine Sodium.

Product ID49502-378_1654f193-aab5-41f7-a038-146382f63dab
NDC49502-378
Product TypeHuman Prescription Drug
Proprietary NameERMEZA
Generic NameLevothyroxine Sodium
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2022-12-14
Marketing CategoryNDA /
Application NumberNDA215809
Labeler NameMylan Specialty L.P.
Substance NameLEVOTHYROXINE SODIUM
Active Ingredient Strength30 ug/mL
Pharm ClassesThyroxine [CS], l-Thyroxine [EPC]
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 49502-378-15

1 BOTTLE, GLASS in 1 CARTON (49502-378-15) > 150 mL in 1 BOTTLE, GLASS
Marketing Start Date2022-12-14
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "ERMEZA" or generic name "Levothyroxine Sodium"

NDCBrand NameGeneric Name
0074-3727SynthroidLevothyroxine Sodium
0074-4341SynthroidLevothyroxine Sodium
0074-4552SynthroidLevothyroxine Sodium
0074-5182SynthroidLevothyroxine Sodium
0074-6594SynthroidLevothyroxine Sodium
0074-6624SynthroidLevothyroxine Sodium
0074-7068SynthroidLevothyroxine Sodium
0074-7069SynthroidLevothyroxine Sodium

Trademark Results [ERMEZA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ERMEZA
ERMEZA
88826046 not registered Live/Pending
Mylan Pharmaceuticals, Inc.
2020-03-09
ERMEZA
ERMEZA
87214828 not registered Dead/Abandoned
Mylan Pharmaceuticals, Inc.
2016-10-25
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.