Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080224
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SORBITOL-MANNITOL MANNITOL; SORBITOL 540MG/100ML;2.7GM/100ML SOLUTION;IRRIGATION 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
08/20/1971 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/20/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/08/1984 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

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