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

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