Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080416
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE 1% INJECTABLE;INJECTION Discontinued None No No
PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE 2% 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
09/15/1972 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
05/15/2000 SUPPL-34 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/02/2000 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/20/1998 SUPPL-32 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/20/1998 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

10/21/1997 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/03/1996 SUPPL-29 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/22/1996 SUPPL-28 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/20/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/03/1989 SUPPL-25 Labeling

Label is not available on this site.

04/21/1988 SUPPL-24 Labeling

Label is not available on this site.

05/06/1987 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/14/1982 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

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