Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019523
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYSTEINE HYDROCHLORIDE CYSTEINE HYDROCHLORIDE 7.25% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
10/22/1986 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

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