Drugs@FDA: FDA-Approved Drugs
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 |
|---|---|---|---|---|---|
| 08/05/2019 | SUPPL-106 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/013684s106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/013684Orig1s106ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 08/05/2019 | SUPPL-106 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/013684s106lbl.pdf | |
| 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 |