Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019284
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OCL POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE 6GM/100ML;75MG/100ML;168MG/100ML;146MG/100ML;1.29GM/100ML SOLUTION;ORAL 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
04/30/1986 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/17/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-13 Labeling

Label is not available on this site.

11/04/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-11 Labeling

Label is not available on this site.

02/03/1998 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/07/2007 SUPPL-9 Labeling

Label is not available on this site.

07/30/1996 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1992 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/22/1988 SUPPL-5 Labeling

Label is not available on this site.

09/30/1988 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/25/1987 SUPPL-3 Labeling

Label is not available on this site.

09/30/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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