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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017015
Company: ORGANON USA INC

Products on NDA 017015

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PAVULON	PANCURONIUM BROMIDE	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
PAVULON	PANCURONIUM BROMIDE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017015

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/24/1972	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/24/2010	SUPPL-23	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017015s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017015s023ltr.pdf
03/22/2000	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
02/28/1994	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
05/17/1995	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
10/05/1990	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
07/25/1991	SUPPL-18	Labeling		Label is not available on this site.
03/29/1993	SUPPL-16	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
10/08/1987	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
06/27/1986	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
04/02/1986	SUPPL-10	Labeling		Label is not available on this site.
03/17/1982	SUPPL-9	Labeling		Label is not available on this site.
03/17/1982	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
01/26/1977	SUPPL-7	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
09/22/1975	SUPPL-6	Labeling		Label is not available on this site.
10/08/1974	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
11/11/1974	SUPPL-3	Labeling		Label is not available on this site.

Labels for NDA 017015

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/24/2010	SUPPL-23	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017015s023lbl.pdf

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