Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019946
Company: ABBVIE

Products on NDA 019946

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019946

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.

Labels for NDA 019946

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