Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080259
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMPT PHENYTOIN SODIUM PHENYTOIN SODIUM 100MG PROMPT CAPSULE;ORAL 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
04/06/1978 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
07/29/2002 SUPPL-49 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-48 Manufacturing (CMC)-Facility

Label is not available on this site.

03/28/2000 SUPPL-47 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-46 Manufacturing (CMC)-Facility

Label is not available on this site.

11/23/1999 SUPPL-45 Manufacturing (CMC)-Facility

Label is not available on this site.

08/20/1999 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

04/30/1993 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

02/23/1993 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

02/23/1993 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

07/17/1992 SUPPL-38 Labeling

Label is not available on this site.

08/07/1989 SUPPL-37 Labeling

Label is not available on this site.

06/26/1989 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

09/10/1987 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

09/10/1987 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

04/13/1987 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

04/13/1987 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/13/1987 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

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