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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073617
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENTAMIDINE ISETHIONATE PENTAMIDINE ISETHIONATE 300MG/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
12/18/1995 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
07/11/1997 SUPPL-2 Labeling

Label is not available on this site.

09/18/1996 SUPPL-1 Labeling

Label is not available on this site.

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