Drugs@FDA: FDA-Approved Drugs
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 |
|---|---|---|---|---|---|
| 03/17/2020 | SUPPL-56 | Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/016269s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/016269Orig1s056ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 03/17/2020 | SUPPL-56 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/016269s056lbl.pdf | |
| 03/17/2020 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/016269s056lbl.pdf | |
| 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 5%
There are no Therapeutic Equivalents.