Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080677
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MANNITOL 25% MANNITOL 12.5GM/50ML 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
08/11/1972 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/14/1995 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

04/08/1993 SUPPL-34 Labeling

Label is not available on this site.

05/01/1992 SUPPL-33 Labeling

Label is not available on this site.

06/19/1991 SUPPL-32 Labeling

Label is not available on this site.

12/06/1994 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/13/1999 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/11/1989 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/11/1989 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/12/1985 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/18/1985 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/10/1985 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/20/1983 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/01/1982 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/08/1982 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

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

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