Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083051
Company: INTL MEDICATION
Company: INTL MEDICATION
| 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 |
|---|---|---|---|---|---|---|---|
| 08/29/1975 | 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 |
|---|---|---|---|---|---|
| 09/19/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/14/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/29/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/07/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 12/17/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/07/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 01/29/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/29/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |