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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019603
Company: ICU MEDICAL INC

Products on NDA 019603

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019603

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
04/29/2020	SUPPL-40	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019603s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019603Orig1s040ltr.pdf
01/09/2019	SUPPL-38	Labeling-Package Insert, Labeling-Container/Carton Labels	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.

Labels for NDA 019603

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2020	SUPPL-40	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019603s040lbl.pdf
01/09/2019	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019603s038lbl.pdf
01/09/2019	SUPPL-38	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019603s038lbl.pdf

Therapeutic Equivalents for NDA 019603

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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