Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075218
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VECURONIUM BROMIDE VECURONIUM BROMIDE 10MG/VIAL INJECTABLE;INJECTION Discontinued None No No
VECURONIUM BROMIDE VECURONIUM BROMIDE 20MG/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
08/23/1999 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75218ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75218ta.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/26/2018 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/22/2011 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

04/20/2001 SUPPL-1 Labeling

Label is not available on this site.

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