NDC 71800-012

Yosprala

Aspirin And Omeprazole

Yosprala is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Innovida Phamaceutique Corporation. The primary component is Aspirin; Omeprazole.

Product ID71800-012_af9f5ec8-af86-4796-a233-9986b8ae44ac
NDC71800-012
Product TypeHuman Prescription Drug
Proprietary NameYosprala
Generic NameAspirin And Omeprazole
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-07-17
Marketing CategoryNDA / NDA
Application NumberNDA205103
Labeler NameInnovida Phamaceutique Corporation
Substance NameASPIRIN; OMEPRAZOLE
Active Ingredient Strength81 mg/1; mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71800-012-30

30 TABLET, FILM COATED in 1 BOTTLE (71800-012-30)
Marketing Start Date2019-07-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71800-012-30 [71800001230]

Yosprala TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA205103
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-17

Drug Details

NDC Crossover Matching brand name "Yosprala" or generic name "Aspirin And Omeprazole"

NDCBrand NameGeneric Name
64950-424Yospralaaspirin and omeprazole
64950-425Yospralaaspirin and omeprazole
68071-5102YospralaYosprala
70347-081YOSPRALAAspirin and Omeprazole
70347-325YOSPRALAAspirin and Omeprazole
71800-012Yospralaaspirin and omeprazole
71800-016Yospralaaspirin and omeprazole
73568-004Yospralaaspirin and omeprazole
73568-005Yospralaaspirin and omeprazole
71800-014aspirin and omeprazole delayed-release tabaspirin and omeprazole
71800-018aspirin and omeprazole delayed-release tabaspirin and omeprazole
73457-415aspirin and omeprazole delayed-release tabaspirin and omeprazole
69597-348ASPIRIN/OMEPRAZOLEaspirin and omeprazole

Trademark Results [Yosprala]

Mark Image

Registration | Serial
Company
Trademark
Application Date
YOSPRALA
YOSPRALA
87107388 not registered Dead/Abandoned
POZEN Inc
2016-07-18
YOSPRALA
YOSPRALA
86011803 5124592 Live/Registered
POZEN Inc.
2013-07-16

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