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:

• Robin Wiscovitch

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
Prednisolone Sodium Phosphate Burke Therapeutics, Pharmaceutical Associates, Inc.	Prescription Medication	2020-11-10
Prednisolone Sodium Phosphate Burke Therapeutics, Pharmaceutical Associates, Inc.	Prescription Medication	2019-11-07
Prednisolone Sodium Phosphate Burke Therapeutics, Pharmaceutical Associates, Inc.	Prescription Medication	2018-11-01
NDC 69101-620 Burke Therapeutics	Hydrocodone Bitartrate And Guaifenesin	2018-10-02
NDC 69101-410 Burke Therapeutics	Prednisolone Sodium Phosphate	2018-06-12

Similar & Related FDA Registered Companies

• Burke Therapeutics, LLC
• Pharmaceutical Associates, Inc.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020061018305	Haifa,Israel -> Houston, Texas	460 CARTONS ON 32 PALLETS OF CONSENSI TEM: + 20 C VE NT:6179124	460 CTN