Drugs@FDA: FDA-Approved Drugs
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. |
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04/08/1993 | SUPPL-34 | Labeling |
Label is not available on this site. |
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05/01/1992 | SUPPL-33 | Labeling |
Label is not available on this site. |
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06/19/1991 | SUPPL-32 | Labeling |
Label is not available on this site. |
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12/06/1994 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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08/13/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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01/11/1989 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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01/11/1989 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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12/12/1985 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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10/18/1985 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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01/10/1985 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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09/20/1983 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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11/01/1982 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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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 |