Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019946
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.

12/05/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/30/2000 SUPPL-4 Labeling

Label is not available on this site.

12/08/1994 SUPPL-2 Efficacy-New Patient Population

Label is not available on this site.

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

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