Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016080
Company: B BRAUN
Company: B BRAUN
| 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 10% W/ DEXTROSE 5% IN DISTILLED WATER | MANNITOL | 10GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MANNITOL 15% | MANNITOL | 15GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% | MANNITOL | 15GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MANNITOL 20% | MANNITOL | 20GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MANNITOL 5% | MANNITOL | 5GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% | 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 |
|---|---|---|---|---|---|---|---|
| 10/08/1965 | 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 |
|---|---|---|---|---|---|
| 05/24/1985 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 05/16/1985 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 04/06/1985 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/09/1984 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/04/1981 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/11/1981 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 05/24/1982 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 12/17/1981 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/01/1979 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/08/1977 | SUPPL-3 | Labeling |
Label is not available on this site. |