Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 000004
Company: PHARMICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAREDRINE HYDROXYAMPHETAMINE HYDROBROMIDE 1% SOLUTION/DROPS;OPHTHALMIC Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/16/1969 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/26/1987 SUPPL-11 Labeling

Label is not available on this site.

05/08/1980 SUPPL-10 Labeling

Label is not available on this site.

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