Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019292
Company: LIEBEL-FLARSHEIM
Company: LIEBEL-FLARSHEIM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MD-76R | DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM | 66%;10% | 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 |
---|---|---|---|---|---|---|---|
09/29/1989 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
04/05/2017 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019292s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019292ig1s011ltr.pdf | |
07/06/2015 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019292s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019292Orig1s010ltr.pdf | |
05/10/2013 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/13/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
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07/25/1996 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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08/28/1992 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
12/04/1992 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/11/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
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03/30/1990 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/09/1990 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/04/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/05/2017 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019292s011lbl.pdf | |
07/06/2015 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019292s010lbl.pdf |