Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083263
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALCOHOL 5% IN D5-W ALCOHOL; DEXTROSE 5ML/100ML;5GM/100ML INJECTABLE;INJECTION 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
02/26/1974 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
06/26/2001 SUPPL-21 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/06/1998 SUPPL-20 Labeling

Label is not available on this site.

11/02/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

09/20/1996 SUPPL-18 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/18/1984 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/23/1982 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

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