Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089744
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENYTOIN SODIUM PHENYTOIN SODIUM 50MG/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
12/18/1987 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
01/29/2014 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

02/14/2001 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/25/1998 SUPPL-7 Labeling

Label is not available on this site.

12/22/1995 SUPPL-6 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/08/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/28/1991 SUPPL-3 Labeling

Label is not available on this site.

03/01/1990 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/06/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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