Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080677
Company: FRESENIUS KABI USA
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. |
||
| 04/08/1993 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 05/01/1992 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 06/19/1991 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 12/06/1994 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1999 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1989 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1989 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1985 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1985 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/1985 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1983 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/1982 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 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 |