Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013684
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OSMITROL 10% IN WATER MANNITOL 10GM/100ML INJECTABLE;INJECTION Prescription AP No No
OSMITROL 10% IN WATER IN PLASTIC CONTAINER MANNITOL 10GM/100ML INJECTABLE;INJECTION Prescription AP No No
OSMITROL 15% IN WATER MANNITOL 15GM/100ML INJECTABLE;INJECTION Prescription AP No No
OSMITROL 15% IN WATER IN PLASTIC CONTAINER MANNITOL 15GM/100ML INJECTABLE;INJECTION Prescription AP No No
OSMITROL 20% IN WATER MANNITOL 20GM/100ML INJECTABLE;INJECTION Prescription AP No No
OSMITROL 20% IN WATER IN PLASTIC CONTAINER MANNITOL 20GM/100ML INJECTABLE;INJECTION Prescription AP No No
OSMITROL 5% IN WATER MANNITOL 5GM/100ML INJECTABLE;INJECTION Prescription AP No No
OSMITROL 5% IN WATER IN PLASTIC CONTAINER MANNITOL 5GM/100ML INJECTABLE;INJECTION Prescription AP 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
06/08/1964 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
11/15/2018 SUPPL-104 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/013684s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/013684Orig1098, s10ltr.pdf
12/23/2015 SUPPL-101 Manufacturing (CMC)

Label is not available on this site.

07/15/2015 SUPPL-100 Manufacturing (CMC)

Label is not available on this site.

04/08/2015 SUPPL-99 Manufacturing (CMC)

Label is not available on this site.

11/15/2018 SUPPL-98 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/013684s098lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/013684Orig1098, s10ltr.pdf
07/19/2013 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

08/26/2005 SUPPL-92 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf
06/09/2005 SUPPL-91 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s091ltr.pdf
01/16/2002 SUPPL-87 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/2001 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

11/24/1999 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

04/29/1997 SUPPL-84 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1994 SUPPL-83 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1994 SUPPL-82 Manufacturing (CMC)-Control

Label is not available on this site.

06/01/1994 SUPPL-81 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1991 SUPPL-79 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1991 SUPPL-78 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1991 SUPPL-77 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1989 SUPPL-76 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1987 SUPPL-75 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/28/1987 SUPPL-74 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1985 SUPPL-71 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1985 SUPPL-70 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1984 SUPPL-69 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1984 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1983 SUPPL-67 Labeling

Label is not available on this site.

08/28/1985 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1985 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1984 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1985 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1982 SUPPL-60 Labeling

Label is not available on this site.

02/16/1982 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1981 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1982 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1982 SUPPL-55 Labeling

Label is not available on this site.

04/16/1982 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1981 SUPPL-53 Labeling

Label is not available on this site.

11/22/1982 SUPPL-51 Labeling

Label is not available on this site.

11/22/1982 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1981 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1981 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1980 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1981 SUPPL-46 Labeling

Label is not available on this site.

09/08/1981 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1981 SUPPL-44 Labeling

Label is not available on this site.

09/08/1981 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1981 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1980 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1980 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1980 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/1980 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1979 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1978 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1978 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/1978 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1980 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1978 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1978 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1978 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1977 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1979 SUPPL-25 Labeling

Label is not available on this site.

04/25/1979 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/30/1977 SUPPL-23 Labeling

Label is not available on this site.

02/07/1977 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/07/1976 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/1976 SUPPL-20 Labeling

Label is not available on this site.

04/08/1977 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1976 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1976 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/1976 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1975 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/1975 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1975 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1975 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/1975 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

11/11/1974 SUPPL-8

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/15/2018 SUPPL-104 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/013684s104lbl.pdf
11/15/2018 SUPPL-98 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/013684s098lbl.pdf
08/26/2005 SUPPL-92 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf
06/09/2005 SUPPL-91 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s091lbl.pdf

OSMITROL 10% IN WATER

INJECTABLE;INJECTION; 10GM/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MANNITOL 10% IN PLASTIC CONTAINER MANNITOL 10GM/100ML INJECTABLE;INJECTION Prescription No AP 020006 B BRAUN
OSMITROL 10% IN WATER MANNITOL 10GM/100ML INJECTABLE;INJECTION Prescription No AP 013684 BAXTER HLTHCARE
OSMITROL 10% IN WATER IN PLASTIC CONTAINER MANNITOL 10GM/100ML INJECTABLE;INJECTION Prescription No AP 013684 BAXTER HLTHCARE

OSMITROL 10% IN WATER IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 10GM/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MANNITOL 10% IN PLASTIC CONTAINER MANNITOL 10GM/100ML INJECTABLE;INJECTION Prescription No AP 020006 B BRAUN
OSMITROL 10% IN WATER MANNITOL 10GM/100ML INJECTABLE;INJECTION Prescription No AP 013684 BAXTER HLTHCARE
OSMITROL 10% IN WATER IN PLASTIC CONTAINER MANNITOL 10GM/100ML INJECTABLE;INJECTION Prescription No AP 013684 BAXTER HLTHCARE

OSMITROL 15% IN WATER

INJECTABLE;INJECTION; 15GM/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MANNITOL 15% IN PLASTIC CONTAINER MANNITOL 15GM/100ML INJECTABLE;INJECTION Prescription No AP 020006 B BRAUN
OSMITROL 15% IN WATER MANNITOL 15GM/100ML INJECTABLE;INJECTION Prescription No AP 013684 BAXTER HLTHCARE
OSMITROL 15% IN WATER IN PLASTIC CONTAINER MANNITOL 15GM/100ML INJECTABLE;INJECTION Prescription No AP 013684 BAXTER HLTHCARE

OSMITROL 15% IN WATER IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 15GM/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MANNITOL 15% IN PLASTIC CONTAINER MANNITOL 15GM/100ML INJECTABLE;INJECTION Prescription No AP 020006 B BRAUN
OSMITROL 15% IN WATER MANNITOL 15GM/100ML INJECTABLE;INJECTION Prescription No AP 013684 BAXTER HLTHCARE
OSMITROL 15% IN WATER IN PLASTIC CONTAINER MANNITOL 15GM/100ML INJECTABLE;INJECTION Prescription No AP 013684 BAXTER HLTHCARE

OSMITROL 20% IN WATER

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

OSMITROL 20% IN WATER 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

OSMITROL 5% IN WATER

INJECTABLE;INJECTION; 5GM/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MANNITOL 5% IN PLASTIC CONTAINER MANNITOL 5GM/100ML INJECTABLE;INJECTION Prescription No AP 020006 B BRAUN
OSMITROL 5% IN WATER MANNITOL 5GM/100ML INJECTABLE;INJECTION Prescription No AP 013684 BAXTER HLTHCARE
OSMITROL 5% IN WATER IN PLASTIC CONTAINER MANNITOL 5GM/100ML INJECTABLE;INJECTION Prescription No AP 013684 BAXTER HLTHCARE

OSMITROL 5% IN WATER IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MANNITOL 5% IN PLASTIC CONTAINER MANNITOL 5GM/100ML INJECTABLE;INJECTION Prescription No AP 020006 B BRAUN
OSMITROL 5% IN WATER MANNITOL 5GM/100ML INJECTABLE;INJECTION Prescription No AP 013684 BAXTER HLTHCARE
OSMITROL 5% IN WATER IN PLASTIC CONTAINER MANNITOL 5GM/100ML INJECTABLE;INJECTION Prescription No AP 013684 BAXTER HLTHCARE

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