Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089703
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/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
04/07/1988 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
02/14/2001 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/24/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/10/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/17/1998 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/17/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/22/1995 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/22/1993 SUPPL-9 Labeling

Label is not available on this site.

07/29/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/29/1993 SUPPL-7 Labeling

Label is not available on this site.

02/01/1991 SUPPL-5 Labeling

Label is not available on this site.

11/30/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/06/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/19/1989 SUPPL-2 Labeling

Label is not available on this site.

06/06/1988 SUPPL-1 Labeling

Label is not available on this site.

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