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FDA Summary Basis of Approval for NDA N01228 – Robaxisal (Approved Before 1982)
FDA Summary Basis of Approval for NDA N01228 – Robaxisal (Approved Before 1982)
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Original Request: Requesting the Summary Basis of Approval for NDA #N01228. Please note this was approved prior to 1982. Drug Product: Robaxisal 325MG; 400MG NDA #: N01228 Approval Date: Approved Prior to Jan 1, 1982 Applicant Holder Full Name: AH ROBINS CO Applicant Address: Barrio San Fernando, Cr 55 No. 71 - 45 Bogota DC - COLOMBIA
Tags: Pharma, NDA, 1982
Tags: Pharma, NDA, 1982
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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