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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074753
Company: BAXTER HLTHCARE CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATRACURIUM BESYLATE 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
01/23/1997 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/17/2000 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

02/17/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

11/22/1999 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

11/22/1999 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

11/22/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/22/1997 SUPPL-1 Labeling

Label is not available on this site.

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