Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019284
Company: HOSPIRA

Products on NDA 019284

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019284

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.