Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087409
Company: LUITPOLD
Company: LUITPOLD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MANNITOL 25% | MANNITOL | 12.5GM/50ML | 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 |
|---|---|---|---|---|---|---|---|
| 01/21/1982 | 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 |
|---|---|---|---|---|---|
| 10/27/1997 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1997 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/22/1991 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/22/1991 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1989 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 04/22/1991 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/22/1991 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/17/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/22/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |