Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088432
Company: ICU MEDICAL INC
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE | MEPERIDINE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 08/16/1984 | 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 |
|---|---|---|---|---|---|
| 12/16/2016 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/22/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/16/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/16/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/30/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 03/06/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 08/28/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |