Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020006
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MANNITOL 10% IN PLASTIC CONTAINER | MANNITOL | 10GM/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| MANNITOL 15% IN PLASTIC CONTAINER | MANNITOL | 15GM/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| MANNITOL 20% IN PLASTIC CONTAINER | MANNITOL | 20GM/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| MANNITOL 5% 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 |
|---|---|---|---|---|---|---|---|
| 07/26/1993 | 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 |
|---|---|---|---|---|---|
| 09/24/2019 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020006s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020006Orig1s028ltr.pdf | |
| 01/09/2019 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020006s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020006Orig1s025ltr.pdf | |
| 04/20/2005 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/01/2002 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/15/2002 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/07/2000 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/21/1998 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 09/24/2019 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020006s028lbl.pdf | |
| 01/09/2019 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020006s025lbl.pdf |
MANNITOL 10% 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 |
MANNITOL 15% 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 |
MANNITOL 20% 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 |
MANNITOL 5% 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 |