Regulations.gov document

REF 2 - Drug Safety and Availability _ Notification re Letter from FDA CDER to Watson…

Supporting & Related Material · FDA-2019-N-3723 · posted Nov 1, 2019

Key facts

Document ID FDA-2019-N-3723-0004
Title REF 2 - Drug Safety and Availability _ Notification re Letter from FDA CDER to Watson Laboratories re Proposal to Withdraw Approval of an Abbreviated New Drug Application for Oxycodone Hydrochloride and Ibuprofen Tablets (ANDA 078394); Opportunity for a Hearing
Document type Supporting & Related Material
Subtype Background Material
Agency FDA
Docket FDA-2019-N-3723
Posted Nov 1, 2019

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