Burke Therapeutics

FDA Filings

This page includes the latest FDA filings for Burke Therapeutics. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Burke Therapeutics holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
Burke Therapeutics, Pharmaceutical Associates, Inc.
Prescription Medication2020-11-10
Burke Therapeutics, Pharmaceutical Associates, Inc.
Prescription Medication2019-11-07
Burke Therapeutics, Pharmaceutical Associates, Inc.
Prescription Medication2018-11-01
Burke Therapeutics
Hydrocodone Bitartrate And Guaifenesin2018-10-02
Burke Therapeutics
Prednisolone Sodium Phosphate2018-06-12

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020061018305Haifa,Israel -> Houston, Texas460 CARTONS ON 32 PALLETS OF CONSENSI TEM: + 20 C VE NT:6179124460 CTN
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