Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016269
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MANNITOL 10% MANNITOL 10GM/100ML INJECTABLE;INJECTION Discontinued None No No
MANNITOL 15% MANNITOL 15GM/100ML INJECTABLE;INJECTION Discontinued None No No
MANNITOL 20% MANNITOL 20GM/100ML INJECTABLE;INJECTION Discontinued None No No
MANNITOL 25% MANNITOL 12.5GM/50ML INJECTABLE;INJECTION Discontinued None No No
MANNITOL 25% MANNITOL 12.5GM/50ML INJECTABLE;INJECTION Prescription AP No No
MANNITOL 5% 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
12/22/1967 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-55 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016269s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016269Orig1s055ltr.pdf
10/08/2015 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

04/08/2015 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

11/18/2002 SUPPL-43 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/05/2002 SUPPL-41 Labeling

Label is not available on this site.

01/17/1997 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

08/14/1995 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

08/25/1994 SUPPL-37 Labeling

Label is not available on this site.

06/04/1991 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

02/01/1988 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

11/22/1985 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/05/1983 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/05/1982 SUPPL-31 Labeling

Label is not available on this site.

09/01/1981 SUPPL-30 Labeling

Label is not available on this site.

02/02/1981 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/04/1982 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/17/1982 SUPPL-27 Labeling

Label is not available on this site.

01/13/1981 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/25/1980 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/02/1980 SUPPL-24 Labeling

Label is not available on this site.

09/03/1980 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/10/1980 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/06/1980 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/27/1980 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/08/1980 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/22/1980 SUPPL-18 Labeling

Label is not available on this site.

07/22/1980 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/18/1978 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/02/1977 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/07/1978 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/04/1977 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/01/1976 SUPPL-12 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-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016269s055lbl.pdf

MANNITOL 10%

There are no Therapeutic Equivalents.

MANNITOL 15%

There are no Therapeutic Equivalents.

MANNITOL 20%

There are no Therapeutic Equivalents.

MANNITOL 25%

INJECTABLE;INJECTION; 12.5GM/50ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MANNITOL 25% MANNITOL 12.5GM/50ML INJECTABLE;INJECTION Prescription No AP 080677 FRESENIUS KABI USA
MANNITOL 25% MANNITOL 12.5GM/50ML INJECTABLE;INJECTION Prescription No AP 016269 HOSPIRA
MANNITOL 25% MANNITOL 12.5GM/50ML INJECTABLE;INJECTION Prescription No AP 083051 INTL MEDICATION
MANNITOL 25% MANNITOL 12.5GM/50ML INJECTABLE;INJECTION Prescription No AP 087409 LUITPOLD

MANNITOL 5%

There are no Therapeutic Equivalents.

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