Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019946
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NUROMAX | DOXACURIUM CHLORIDE | EQ 1MG BASE/ML | 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 |
---|---|---|---|---|---|---|---|
03/07/1991 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
11/22/2010 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019946s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019946s007ltr.pdf | |
05/30/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
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12/05/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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05/30/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
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12/08/1994 | SUPPL-2 | Efficacy-New Patient Population |
Label is not available on this site. |
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01/24/1992 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/22/2010 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019946s007lbl.pdf |