Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074944
Company: WATSON LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATRACURIUM BESYLATE PRESERVATIVE FREE ATRACURIUM BESYLATE 10MG/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
07/28/1998 ORIG-1 Approval Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74944ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/074944_atracurium_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/26/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

04/28/2000 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

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