Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019603
Company: ICU MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MANNITOL 10% IN PLASTIC CONTAINER MANNITOL 10GM/100ML INJECTABLE;INJECTION Discontinued None No No
MANNITOL 15% IN PLASTIC CONTAINER MANNITOL 15GM/100ML INJECTABLE;INJECTION Discontinued None No No
MANNITOL 20% IN PLASTIC CONTAINER MANNITOL 20GM/100ML INJECTABLE;INJECTION Prescription AP No No
MANNITOL 5% IN PLASTIC CONTAINER MANNITOL 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
01/08/1987 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
01/09/2019 SUPPL-38 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019603s038lbl.pdf
07/10/2000 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/11/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/06/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/04/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/14/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/29/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/25/1994 SUPPL-10 Labeling

Label is not available on this site.

01/28/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/10/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/04/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/11/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/08/1990 SUPPL-2 Labeling

Label is not available on this site.

01/08/1990 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/09/2019 SUPPL-38 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019603s038lbl.pdf
01/09/2019 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019603s038lbl.pdf

MANNITOL 10% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

MANNITOL 15% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

MANNITOL 20% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 20GM/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MANNITOL 20% IN PLASTIC CONTAINER MANNITOL 20GM/100ML INJECTABLE;INJECTION Prescription No AP 020006 B BRAUN
MANNITOL 20% IN PLASTIC CONTAINER MANNITOL 20GM/100ML INJECTABLE;INJECTION Prescription No AP 019603 ICU MEDICAL INC
OSMITROL 20% IN WATER MANNITOL 20GM/100ML INJECTABLE;INJECTION Prescription No AP 013684 BAXTER HLTHCARE
OSMITROL 20% IN WATER IN PLASTIC CONTAINER MANNITOL 20GM/100ML INJECTABLE;INJECTION Prescription No AP 013684 BAXTER HLTHCARE

MANNITOL 5% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

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