Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084307
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENYTOIN SODIUM PHENYTOIN SODIUM 50MG/ML INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/16/1975 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
01/27/2014 SUPPL-47 Labeling-Package Insert

Label is not available on this site.

01/27/2014 SUPPL-46 Labeling-Package Insert

Label is not available on this site.

12/11/1998 SUPPL-38 Labeling

Label is not available on this site.

08/19/1998 SUPPL-37 Labeling

Label is not available on this site.

02/09/1998 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

05/27/1997 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

05/27/1997 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

06/10/1997 SUPPL-33 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/27/1995 SUPPL-32 Labeling

Label is not available on this site.

11/18/1993 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

07/31/1991 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/28/1990 SUPPL-28 Labeling

Label is not available on this site.

05/18/1990 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

07/24/1989 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/10/1988 SUPPL-24 Labeling

Label is not available on this site.

11/18/1985 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/02/1987 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/02/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/02/1987 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/18/1985 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/01/1984 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/14/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

PHENYTOIN SODIUM

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PHENYTOIN SODIUM PHENYTOIN SODIUM 50MG/ML INJECTABLE;INJECTION Prescription No AP 040573 ACELLA
PHENYTOIN SODIUM PHENYTOIN SODIUM 50MG/ML INJECTABLE;INJECTION Prescription No AP 084307 WEST-WARD PHARMS INT

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