Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074598
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 10MG/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
06/19/1997 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
08/29/2007 SUPPL-11 Labeling

Label is not available on this site.

12/03/2002 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/2001 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/29/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/29/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/14/2003 SUPPL-2 Labeling

Label is not available on this site.

06/29/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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