Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074755
Company: NORVIUM BIOSCIENCE
Company: NORVIUM BIOSCIENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IPRATROPIUM BROMIDE | IPRATROPIUM BROMIDE | 0.02% | SOLUTION;INHALATION | 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 |
---|---|---|---|---|---|---|---|
01/10/1997 | 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 |
---|---|---|---|---|---|
12/07/2012 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/074755Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/074755Orig1s025ltr.pdf | |
02/20/2007 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/26/2004 | SUPPL-15 | Labeling |
Label is not available on this site. |
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04/01/2004 | SUPPL-13 | Labeling |
Label is not available on this site. |
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12/20/2002 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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12/20/2002 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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12/18/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/31/2001 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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05/24/2000 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/24/2000 | SUPPL-3 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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10/14/1997 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/07/2012 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/074755Orig1s025lbl.pdf |