Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070915
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 10MG/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
02/03/1989 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
12/16/2016 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

11/30/2007 SUPPL-18 Labeling

Label is not available on this site.

10/25/2002 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/12/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/05/1998 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/27/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/27/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/27/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/03/1996 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/26/1996 SUPPL-5 Labeling

Label is not available on this site.

02/28/1991 SUPPL-3 Labeling

Label is not available on this site.

07/25/1990 SUPPL-2 Labeling

Label is not available on this site.

NALBUPHINE HYDROCHLORIDE

INJECTABLE;INJECTION; 10MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 070914 HOSPIRA
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 070915 HOSPIRA
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 206506 MYLAN LABS LTD
NALBUPHINE HYDROCHLORIDE NALBUPHINE HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 207595 MYLAN LABS LTD

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