NDC 35573-446

TROSPIUM CHLORIDE ER

Trospium Chloride Er

TROSPIUM CHLORIDE ER is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Burel Pharmaceuticals, Inc.. The primary component is Trospium Chloride.

Product ID35573-446_80c44b96-82e9-4742-838b-2a86bee22865
NDC35573-446
Product TypeHuman Prescription Drug
Proprietary NameTROSPIUM CHLORIDE ER
Generic NameTrospium Chloride Er
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2021-04-12
Marketing CategoryANDA /
Application NumberANDA213185
Labeler NameBurel Pharmaceuticals, Inc.
Substance NameTROSPIUM CHLORIDE
Active Ingredient Strength60 mg/1
Pharm ClassesCholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 35573-446-30

30 CAPSULE in 1 BOTTLE (35573-446-30)
Marketing Start Date2021-04-12
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "TROSPIUM CHLORIDE ER" or generic name "Trospium Chloride Er"

NDCBrand NameGeneric Name
35573-446TROSPIUM CHLORIDE ERTROSPIUM CHLORIDE ER
0574-0118Trospium Chloride ERTrospium Chloride ER

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