Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019638
Company: ORGANON USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARDUAN PIPECURONIUM BROMIDE 10MG/VIAL 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
06/26/1990 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-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019638s005ltr.pdf
05/05/1995 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/18/1993 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/24/1991 SUPPL-1 Labeling

Label is not available on this site.

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